Recall Alerts – Drug Regulatory Authority of Pakistan

Rapid Alert – Unregistered / Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

Ahsan Hafiz Recall Alerts September 12, 2025September 12, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / UNREGISTERED DRUGS

Unregistered Indian-Origin Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

DRAP Alert No	N^o I/S/09-25-62
Action Date	12th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	DRAP has identified dangerous and illegal brands of Sildenafil tablets being sold in the market under the names PENAGRA 100 mg, VEGA 100 mg, and COBRA 125 mg tablets. Laboratory testing has declared PENAGRA substandard and all three products unregistered and falsified Indian-origin medicines. These tablets were being sold illegally by paddler in the local market, who has now absconded. Unregistered Drug Products Involved PENAGRA TABLETS 100 mg · Generic: Sildenafil 100 mg/tablet · Batch No.: BPTE-24134 · Manufacturer (as per label): M/s BANSON PHARMACEUTICALS PVT. LTD. · Finding: Declared Substandard on basis of assay of sildenafil; also Unregistered (Falsified) VEGA 100 TABLETS · Generic: Sildenafil 100 mg/tablet · Batch No.: NIL (untraceable) · Manufacturer (as per label): M/s HAB PHARMACEUTICAL & RESEARCH INDIA · Finding: Declared Unregistered (Falsified) COBRA 125 MG TABLETS · Generic: Sildenafil 125 mg/tablet · Batch No.: BCB-98 · Manufacturer (as per label): M/s Combitic Global Caplet Pvt. Ltd., India Finding: Declared Unregistered (Falsified)

Risk Statement	The use of these unregistered brands of sildenafil tablets poses a serious threat to public health. Since PENAGRA has been declared substandard, patients may experience ineffective treatment, unpredictable dosing, or harmful side effects. In addition, PENAGRA, VEGA, and COBRA tablets are all unregistered and falsified products, which means they bypass DRAP’s strict quality, safety, and efficacy checks and may contain unsafe or misleading ingredients. Medicines obtained from the black market, paddlers, or online sellers are especially dangerous, as their authenticity and safety cannot be verified, putting patients at high risk of treatment failure and potential harm. Unregistered medicines are strictly prohibited in Pakistan and may cause serious health risks, including treatment failure and harmful side effects. The public is strongly advised: do not buy or use these unregistered products from pharmacies, online sellers, social media, or black market sources.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Precautionary Recall of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24C001

Ahsan Hafiz Recall Alerts September 12, 2025September 12, 2025Recall

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Rapid Alert

Precautionary Recall of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24C001

DRAP Alert No	N^o I/S/09-25-61
Action Date	12th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	The Drug Regulatory Authority of Pakistan (DRAP) has received reports through the Directorate of Drugs Control, Punjab, regarding multiple serious adverse drug reactions (ADRs) in patients administered Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24C001, manufactured by M/s Caraway Pharmaceuticals, Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. Reported cases include hypersensitivity reactions such as rash, angioedema, shortness of breath, hypotension, and palpitations, which indicate potential risk of life-threatening anaphylactic events.

Risk Statement	Use of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24C001 may result in serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, especially in patients receiving intravenous iron therapy. This batch is therefore classified as a Class I (High-Risk) Recall.
Action Initiated	All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	· Immediately stop use and dispensing of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24C001. · Identify and monitor patients who may have received this batch for signs of hypersensitivity or anaphylaxis. · Retain and segregate any remaining stock and ensure it is not used until further instructions. · Counsel patients regarding the risks and advise on suitable therapeutic alternatives where necessary. DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

Ahsan Hafiz Recall Alerts September 10, 2025September 10, 2025Recall

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/09-25-60
Action Date	10th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the following purported drug product has been declared ‘spurious’ upon analysis and reportedly manufactured by entity not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1	PAYODEN Solution 60mL Each 100ml contains: Povidone-Iodine.10.0g eq. to 1.0g available Iodine (1%w/v)	006	Purported to be manufactured by an unlicensed /illegal entity claimed to be M/s MSL Laboratories Industrial Area, Karachi.	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)

Risk Statement	Purported drug product has been confirmed as falsified/spurious, as manufactured by entity neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). This product being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredient, indicating a complete lack of therapeutic value. The circulation and use of such unregulated product pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

RAPID ALERT – SPURIOUS / FALSIFIED DECLARED BY PROVINCIAL LABORATORIES.

Ahsan Hafiz Recall Alerts September 10, 2025September 10, 2025Recall

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/09-25-59
Action Date	10th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1	TABLET ONSET-8 (REG # 025989) Each Tablet Contains: ondansetron HCl eq. To ondansetron 8 mg)	447	Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. .	Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
2	Capsule Nexum (Reg # 033891) EACH Capsule contains: ENTERIC-COATED PELLETS OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE EQUIVALENT TO ESOMPERAZOLE 40 MG)	C02085	Purported to be manufactured by M/s GETZ PHARMА (PVT) LIMITED., PLOT NO. 01, SECTOR 25, KORANGI INDUSTRIAL AREA. KARACHI.	Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
3	Capsule Maxflow -D (Reg # 033891) EACH Capsule contains: Extended release pellets of Tamsulosin HCl eq. to Tamsulosin HCl …… 0.4mg	QM375	Purported to be manufactured by M/s CCL Pharmaceuticals (Pvt.) Ltd. (DML # 000052) 62 Industrial Estate Kot Lakhpat Lahore.	Drug Testing Laboratory, Multan Punjab declared the purported drug product as ‘Spurious with regard to Dutasteride, misbranded with regard to labelling & substandard on basis of dissolution test and assay of tamsulosin HCl’.
4	Capsule Azomax 250 mg Each Capsule contains: Azithromycin (as di-hydrate) …………………… 250 mg	C3193	Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi.	Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
5	Tablet Rigix Each film coated tablet contains: Cetirizine hydrochloride…….10mg	C3905 C3362	Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. Note: The unit carton bears batch # C3905 while blister bears Batch # C3362. (DDCP Alert No. 171/2025)
6	Fexet Tablet 120mg Each film coated tablet contains: Fexofenadine hydrochloride. ….120mg	F26018	Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., Plot No. 01, Sector 25, Korangi Indsustrial Area, Karachi.	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
7	Capsule Zetro 250 mg Each Capsule contains: Azithromycin (as dihydrate) ……..250 mg	247C21	Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
8	Tablet Duphaston Each film coated tablet contains: Dydrogesterone … 10mg	241476	Purported to be manufactured by M/s Highnoon Laboratories Ltd. 17.5 Km Multan Road Lahore. (DML # 000155) *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
9	Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase 10 mg (20,000 units of Serratiopeptidase)	3602	Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
10	Tablet Terbisil Each Tablet contains: Terbinafine (as HCl) 250 mg	473	Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. (DML # 000616) 19-Km Sheikhupura Road Faisalabad. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
11	Tablet Terbisil Each Tablet contains: Terbinafine (as HCl) 250 mg	473	Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
12	Tablet Azomax 500 mg Each film coated tablet contains : Azithromycin (as di-hydrate) ……..500 mg	C3670	Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
13	Tablet Prism 10 mg Each tablet contains: Escitalopram oxalate eq. to escitalopram ……. 10 mg	25PR02	Purported to be manufactured by M/s Friends Pharma (Pvt) Ltd. (DML # 000531) 31-Km Ferozepur Road Lahore. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
14	Capsule Gabica 300mg Pregabalin l00mg	427C27	Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
15	Tablet Ativan 2 mg Each tablet contains: Lorazepam …… 2 mg	17C7019	Purported to be manufactured by M/s Pfizer Pakistan Ltd. B-2, S.I.T.E. Karachi. *(Recovered from unauthorized person / paddler)*	Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
16	Injection ONSET 4 ml ondansetron HCl eq. To ondansetron 2mg/ml)	829	Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. *(Recovered from unauthorized person / paddler)* .	Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ and ‘substandard’ on the basis of assay. (DDCP Alert No. 178/2025)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious/substandard, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains Low / no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

RECALL ALERT – FAMILA 28F TABLETS (Batch # K159, K196, K197, K198) DECLARED SUBSTANDARD.

Ahsan Hafiz Recall Alerts September 10, 2025September 10, 2025Recall

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DRAP Alert No	N^oII/S/09-25-58
Action Date	10 September, 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K159	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K159) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & weight variation of Ferrous Iron.
2.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K198	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K198) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel & Ethinyl Estradiol.
3.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K196	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K196) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel.
4.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K197	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K197) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel & Ethinyl Estradiol.

Risk Statement:	The affected batches of *Famila 28F Tablets* due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

RECALL ALERT – ANAROB INFUSION DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI

Ahsan Hafiz Recall Alerts September 9, 2025September 9, 2025Recall

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DRAP Alert No	N^oI/S/09-25-57
Action Date	09 September, 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Anarob Infusion Each 100 ml of infusion contains: Metronidazole …500 mg	H24219	M/s Vision Pharmaceuticals (Pvt.) Ltd, (DML # 000517) Plot No. 22-23 Industrial Triangle Kahuta Road Islamabad	Central Drugs Laboratory declared the Anarob Infusion (Batch # H24219) as ‘Substandard’ on the basis of out of specification results for the test Bacterial Endotoxins.

Risk Statement:	The affected batch of Anarob Infusion (Batch # H24219) has been declared out of specification for bacterial endotoxins. Use of this contaminated infusion may cause severe adverse reactions such as fever, chills, septic shock, and life-threatening complications. Hospitalized and immunocompromised patients are at the greatest risk.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCTS

Ahsan Hafiz Recall Alerts August 20, 2025August 20, 2025Recall

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CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/08-25-56
Action Date	20th August, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’*. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1	Brexin Tablet Each tablet contains: Piroxicam-β-Cyclodextrine (Lyophilized) e.q to Piroxicam……20mg	1192087	Purported to be manufactured underlicense of Chiesi Farmaceutici S.P.A., PARMA-ITALY Marketed by: Chiesi Pharmaceuticals Pvt. Ltd., Lahore.	Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
2	Tablet Zetro 500mg (Reg. # 053120) Each film coated tablet contains: Azithromycin (as dihydrate) ………………….500 mg	F18031	Purported to be manufactured underM/s Getz Pharma (Private) Limited. Plot # 01, Sector 25, Korangi Industrial Area, Karachi (DML# 000933).	Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
3	Tablet Augmentin 625mg Each film coated tablet contains: Amoxicillin (as trihydrate) …………… 500 mg. Clavulanic Acid (as potassium salt) …… 125mg.	7F4W	Purported to be manufactured underM/s GlaxoSmithKline Pakistan Limited, F/268, S.I.T.E. Karachi (DML# 000233).	Drug Testing Laboratory, Multan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
4	Tablet TONOFLEX-P Each Film Coated Tablet Contains: Tramadol HCl …… 37.5 mg Paracetamol ……… 325 mg	KFM145	Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, S.I.T.E. Karachi (DML# 000072).	Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
5	Tablet EFASTON Each film coated tablet contains Dydrogesterone …… 10 mg	41160	Purported to be manufactured underM/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064).	Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
6	Capsule Gabica 300 mg Each Capsule contains: Pregabalin ……… 300 mg	403C27	Purported to be manufactured underM/s Getz Pharma (Private) Limited. 29-30/27 Korangi Industrial Area, Karachi (DML# 000284) *(recovered from Peddler / Hawker)*	Drug testing Laboratory Multan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
7	Imcomox Capsule Each Capsule Contains: Amoxycillin trihydrate eq. to Amoxycillin (U.S.P) …. 500mg	08	Purported to be manufactured underM/s IMCO Pharmaceutical Labs. 73- Industiral Estate, Hayatabad, Peshawar. (DML # 000317)	Drug Testing Laboratory, Faisalabad declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
8	Omnidol NU Tablet Each uncoated tablet contains: Paracetamol …….500mg Caffeine …………….65 mg	1220	Purported to be manufactured underM/s Olive Laboratories. Plot No.52-S-6 National Industrial Zone Rawat Rawalpindi. (000524)	Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of caffeine, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Paracetamol, ‘Substandard’ as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
9	CAPSULE CEFSPAN 400 mg Each capsule contains: Cefixime………400mg	F0580	Purported to be manufactured underM/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423 SITE Karachi. (000457)	Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
10	CAPSULE ICON 100 mg Each capsule contains: Itraconazole pellets eq. To itraconazole 100 mg	241694	Purported to be manufactured underM/s Ferozsons Laboratories Ltd. Amangarh Nowshera (DML #000038)	Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
11	Tablet NOVIDAT Each film coated tablet contains: Ciprofloxacin Hydrochloride eq. to Ciprofloxacin 500mg	FIM147	Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt) Ltd. F-95 Off Hub River Road, SITE Karachi. (DML # 000072)	Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

(Please find pictorial guidelines for identification of falsified products in the pdf version to be downloaded from link above)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company—whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.

Ahsan Hafiz Recall Alerts August 18, 2025August 18, 2025Recall

Recall Alert

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DRAP Alert No	N^oII/S/08-25-55
Action Date	18 August, 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K185	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay(Levonorgestrel).
2.	Famila 28F Tablets Each Tablet contains: Levonorgestrel…..0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K189	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay (Levonorgestrel).
3.	Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K187	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), Weight variation of Ferrous Iron and Assay (Levonorgestrel & Ethinyl Estradiol).
4.	Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K192	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel & Ethinyl Estradiol).
5.	Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K194	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).
6.	Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941)	K195	M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490)	‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).
7.	Imcomox 125mg/5ml Suspension Each 5ml of reconstituted suspension contains: Amoxicillin (as Trihydrate) ………………….125mg (Reg. No. 013756)	029	M/s. Imco Pharmaceutical Lab. 73/A Industrial Estate Jamrud Road, Peshawar (DML#000317)	‘Substandard’ on the basis of Assay (Amoxicillin trihydrate).
8.	Imcodal Oral Suspension Each 5ml of Suspension contains: Metronidazole Benzoate.. 64mg Ethinyl Furazolidone….25mg (Reg. No. 013363)	013	M/s. Imco Pharmaceutical Lab. 73/A Industrial Estate Jamrud Road, Peshawar (DML#000317)	‘Substandard’ on the basis of Assay (Furazolidone).

Risk Statement:	Famila 28F: The affected batches of *Famila 28F Tablets* due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities. Imcomox: Laboratory testing has confirmed that the amoxicillin content in this drug product is below the approved specification range, making it subpotent. Such reduced strength may cause treatment failure, particularly in infants and young children, the primary users of this medicine. The recall is being undertaken to prevent potential health risks and safeguard public safety. Imcodal: Laboratory testing has confirmed that the furazolidone content in this suspension is below the approved specification range, indicating subpotency. Inadequate active ingredient may lead to ineffective treatment of gastrointestinal infections, particularly in children, who are the primary recipients of this medicine. This recall is being carried out to prevent treatment failure and protect public health.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

RAPID ALERT – CRACKDOWN AGAINST UNLICENSED/UNAUTHORIZED MANUFACTURERS

Ahsan Hafiz Recall Alerts August 11, 2025August 11, 2025Recall

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/08-25-54
Action Date	11th August, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	The Drug Regulatory Authority of Pakistan (DRAP) has received information from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan, indicating that the following purported drug products have been declared ‘spurious’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1	Missron Tablet Each Tablet contains Dydrogesterone ……. 10mg	48022	M/s Fegga Pharmaceutical, F-21/H.P.T.C., S.I.T.E., KARACHI.	Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
2	Quttefol OD tablets Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcg	QL-001	M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, Lahore	Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of Vitamin B12, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Folic Acid, ‘Substandard’ as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
3	Depasrone Tablets Each Tablet contains Dydrogesterone ……. 10mg	2406	M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi	Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
4	Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg	DRP-0004	M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi	Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

Risk Statement	All the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

VOLUNTARY RECALL ALERT – Amoxil Forte Suspension & Amoxil Suspension due to complaint of Induction Seal.

Ahsan Hafiz Recall Alerts August 5, 2025August 6, 2025Recall

Recall Alert

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DRAP Alert No	N^oII/V/08-25-53
Action Date	05^th August 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	M/s GlaxoSmithKline Pakistan Ltd., F-268, S.I.T.E., Karachi (DML No. 000233) has informed the Drug Regulatory Authority of Pakistan (DRAP) that the following drug products are being voluntarily recalled due to defective induction seal.

Therapeutic Goods (s) Affected: –

S#	Product Name	Manufacturers	Batch No.
1	Amoxil Forte Suspension 250 mg (Reg. # 006814)	M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi (DML # 000233)	7W9V, 7W9W, 7W9X, 8L5H, 8R3M, 8L5J, 8R4J, 8R4G, 8R3N, 8R4M, 8R4N, 8T5A, 9S5D, 9S5B, 9U6F, 9X3E, 9U6E, 9X3G, 9X3F, AH9Y, AJ2A, AP2M, AP2N, AP2P, AP2T, AS5B, AS5K, AS5F, AT7M, AS5L, C25W, C25X, C37E, C37G, C99F, C58B, CB4N, CB4P, CB4R, CD6T, CD6W, CD6V, DL5L, DL5K, DL5M, EE9R, EE9N, DY5U, EE9T, EG2A, FA8M, FA8N, FB9C, FB9D, FB9E, FB9F, FE9X, FF2A
2	Amoxil Suspension 125 mg (Reg. # 000508)	M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi (DML # 000233)	8U3B, 8T5G, 8T5L, 8U3A, 8U3G, 8U3H, 8W9S, 8W9T, 925W, 925Y, 926B, 926A, 956M, 956R, 966V, 967C, 967F, 967E, 988F, 988H, 988G, 9B4P, 988K, 9B4M, 9B4S, 9D6K, 9B4T, 9D6M, 9D6P, 9D6T, 9G4N, 9G4P, 9L9N, 9L9M, 9P7R, 9P7S, 9R2V, 9R2U, 9S4Y, 9S5A, AW3A, AW3B, AW3H, AW3D, AY5T, AY5X, AY5V, AY6B, B44T, B44M, B44S, BB2Y, B44V, BB3A, BB3B, BF3B, BF2X, BB3C, BF3C, BF3A, BT9H, BT9G, BT9F, BT9J, BW8R, BW8M, BW8S, BW8T, BX8L, BX8N, BX8P, CG4V, CG4X, CG4W, CG4Y, CJ7B, CJ6W, CJ7C, CJ7D, CP5G, CP5H, CT5X, CT6A, CW3H, CW3G, CY3A, D64P, D64S, CY3K, EP7E, EN4U, EN4T, EP7J, EP7M, EP7P, ET8M, EW3F, F55S, F32W, F55V, F55U, F55T, F97P, F75G, F75J, F75K, F75N, FT2Y, FU7X, FU7Y, FT3A

Risk Statement:	These drug products are being voluntarily recalled by the manufacturer due to a quality defect related to the defective induction seal of bottles, which may potentially compromise product integrity. The undetected defect may pose risk under certain conditions of storage or use. This recall is being carried out as a precautionary measure in consultation with the Drug Regulatory Authority of Pakistan (DRAP) to safeguard public health.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

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