Product Recalls – Drug Regulatory Authority of Pakistan

Rapid Alert

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

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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

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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.

RECALL ALERT – BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

Ahsan Hafiz Recall Alerts August 4, 2025August 4, 2025Recall

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DRAP Alert No	N^oII/S/08-25-52
Action Date	04 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 product has been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

Product Details: Famila 28F Tablets (Reg. # 023941)

Manufactured by: M/s Zafa Pharmaceuticals Lab (Pvt) Ltd. (DML # 000490)

Batch No.	CDL Test Result / Remarks
K217	‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron).
K177	‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron. Assay test of Levonorgestrel.)
K203, K207	‘Substandard’ on the basis of test of weight variation of Ferrous Iron.
K184, K190, K191	‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Assay test of Levonorgestrel.
K182	‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron.
K199, K205	‘Substandard’ on the basis of tests Content uniformity of Ethinyl Estradiol & Weight variation of Ferrous Iron.
K204	‘Substandard’ on the basis of test of Content uniformity 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. Use of such products can cause therapy failure and complications.
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 – MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

Ahsan Hafiz Recall Alerts July 29, 2025July 29, 2025

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DRAP Alert No	N^oI/S/07-25-51
Action Date	29 July, 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 Drug Regulatory Authority of Pakistan that the samples of below mentioned Medical Devices have been reported as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

Product Names	Batch Details	Manufactured by	Test Results
ZINDAGI Auto Disable Syringe 5ml (MDMR-000117)	5-01E-25	M/s Al-Badar Manufacturing (Pvt.) Ltd. Gadoon Amazai KPK (ELM-0029)	‘Substandard’ on the basis of Sterility Test.
Ultra Fine SMD Painless Syringe 5ml (MDMR-000229)	5053CE	M/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065)	‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
Ultra Fine SMD Painless Syringe 3ml (MDMR-000229)	3022CD	M/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065)	‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).

Risk Statement:	Use of substandard syringes, in invasive or intravenous procedures, poses a significant risk of introducing microbial contaminants into the patient’s body, which may result in localized infections, abscesses, or life-threatening systemic infections, particularly in immunocompromised individuals.
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.

Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Ahsan Hafiz Recall Alerts June 27, 2025June 27, 2025

Recall Alert

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DRAP Alert No	N^oI/S/06-25-50
Action Date	23rd June, 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	The Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

Product Names	Composition	Batch Details	Manufactured by	Test Results
Medistil Injection Reg. No. 064758	Sterile Water for Injection……5ml	25L608	M/s. Medisave Pharmaceuticals, 578-579, Sundar Industrial Estate, Lahore.	‘Substandard’ on the basis of Bacterial Endotoxin Test.
Kanadex-N Cream Reg. No. 012475	Each gram contains: Dexamethasone-21 phosphate as disodium salt…….1mg Neomycin as sulphate…3500 i.u.	F7-27	M/s ISIS Pharmaceuticals & Chemical Works, 25/1-3, Sector 12-C, North Karachi Industrial Area, Karachi.	‘Substandard’ on the basis of Assay of Dexamethasone phosphate.
Bytec Tablet 10mg Reg. No. 036183	Each Film coated tablet contains: Cetirzine dihydrochloride…..10mg	E090	M/s Batala Pharmaceuticals., 23/B Small Industrial Estate #2, Gujranwala.	‘Substandard’ on the basis of Impurities test.
Sterile Water for Injection 5ml Reg. No. 071329	Sterile Water for Injection….5ml	25WF01	M/s Friends Pharma (Pvt) Ltd., 31-Km, Ferozpur Road, Lahore.	‘Substandard’ with regards to visible particulates in injection.
Cetfin 10mg Tablet Reg. No. 091843	Each film coated tablet contains: Cetirizine dihydrochloride ..…..10mg	CT67	M/s. Effort Pharmaceuticals (Pvt.) Ltd, 28-Km, Ferozpur Road, Lahore.	‘Substandard’ on the basis of Test for impurities (Organic impurities).
Kanabax Cream 15g Reg. No. 070880	Each gram contains: Dexamethasone….1mg Neomycin Sulphate….3.5mg	KNX-270	M/s. Baxter Pharmaceuticals, A-1/A, Phase 1, S.I.T.E., Super Highway, Karachi.	‘Misbranded’ with regards to Labeling as per Section 3(s)(iv), ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976, and ‘Substandard’ on the basis of Assay of Neomycin and Dexamethasone Phosphate.
Surgitex Latex Surgical Gloves (powdered) Reg. No. MDIR-0001236	Surgitex Latex Surgical Gloves Size 7.0 Powdered Sterile	20241001	Manufactured by: Suzhou Colour-way New Material Co., Ltd, 20 Anmin Road, Huangdai Town, Xiangcheng District 215152, Suzhou, China. Marketed by: M/s Al-Hamd Enterprises FL-11/1/1, Block-6, Gulshan-e Iqbal, Karachi.	‘Substandard’ with regards to Sterility Test.

Risk Statement:	The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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.

Recall Alert: Recall of Substandard “Famobex Suspension” Batch No. 5330, Manufactured by M/s Cibex (Pvt.) Ltd, Karachi.

Ahsan Hafiz Recall Alerts June 24, 2025June 24, 2025

Recall Alert

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DRAP Alert No	N^oI/S/06-25-49
Action Date	23rd June, 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	Federal Government Analyst, CDL, Karachi vide test report No. KQ-2-25-000015 has declared the sample of subject mentioned batch of the product as of ‘*Substandard*’ quality. Details of the CDL test report are as under:

Therapeutic Goods (s) Affected: –

Product Names	Composition	Batch Details	Manufactured by	Test Results
Famobex Suspension Reg. No. 027108	Each 5ml contains: Famotidine.……10mg	5330	M/s Cibex (Private) Limited., F-405, S.I.T.E, Karachi.	‘Substandard’ on the basis of Assay test.

Risk Statement:	The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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.

Recall Alert: RECALL OF PRODUCTS CONTAINING HYDROXYPROGESTERONE CAPROATE

Ahsan Hafiz Recall Alerts June 23, 2025June 23, 2025

Recall Alert

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DRAP Alert No	N^oI/S/06-25-48
Action Date	16th June, 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	The Registration Board, in its 346^th meeting held on 22^nd April 2025, decided to *‘suspend’* registrations of products containing 17-Hydroxyprogesterone caproate, in light of the decision made by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of the European Medicine Agency (EMA). The details of the marketing authorization holders of the said molecule are provided below:

Therapeutic Goods (s) Affected: –

Product Names	Composition	Manufactured by
GLOBINAN INJECTION 1ML & 2ML Reg. No. 030525 & 030526	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Triangle Kahuta Road, Islamabad.
HYDROXYPROGESTERONE INJECTION Reg. No. 003746	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s Haji Medicines Co, Haji Yasin Block, Plot No. 206& 207, Industrial Triangle, Kahuta Road, Islamabad
NANDROSOL 250MG INJECTION Reg. No. 096479	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s. Pharmasol (Pvt.) Ltd., Plot No. 549, Sundar Industrial Estate, Lahore.
HYGEST INJECTION Reg. No. 094205	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s Shaigan Pharmaceuticals (Pvt.) Ltd, l4 Km, Adyala Road Post Office Daghal, Rawalpindi.
VIO-DEPOT INJECTION Reg. No. 013624	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s. Venus Pharma, 23Km Multan Road Lahore, Lahore.
HYDROXYPROGESTERONE INJECTION Reg. No. 003531	Each ampoule contains: Hydroxyprogesterone caproate …..250mg	M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd., L-4/1, A&8, Block 21, F.B Industrial Area, Karachi.

Risk Statement:	A review by EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-Hydroxyprogesterone Caproate in the womb. In addition, the review considered new studies which showed that the said product is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorized uses.
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.

Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

Ahsan Hafiz Recall Alerts June 23, 2025June 23, 2025

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Rapid Alert

DRAP Alert No	N^oI/S/06-25-47
Action Date	13th June, 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 Directorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared *‘Spurious’*. The details of the report are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

Product	Batch No	Manufacturer Name (as per label)	Remarks
Klaricid Tablet 500mg Each film coated contains: Clarithromycin……500mg	722269XV	M/s Abbott Laboratories (Pakistan) Ltd., Landhi, Karachi.	‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
Terbisil Tablet 250mg Each tablet contains: Terbinafine as hydrochloride……250mg	473	M/s Saffron Pharmaceuticals (Pvt.) Ltd., 19 Km, Sheikhupura Road, Faisalabad.	‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
Carefen Suspension 450mL Each 5mL contains: Ibuprofen.…..100mg	CN-37	M/s Wellcare Pharmaceuticals., A/7 P.S.I.E., Sargodha.	Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
DROPHA Tablet Each film coated tablet contains: Dydrogesterone…..10mg	DRP-0005	M/s Himax Pharmaceutical, Plot No. 445, Korangi Industrial Area, Karachi.	‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
Paracetamol X-tra 1000ml Each 1000ml contains: Paracetamol……190g Brofen……..…..150g Caffein…………….50g Aspirin……….…70g Sorbitol……….150ml	Mt357	M/s Vibra Pharma (Pvt.) Ltd., A-139- Ferozpur Road, Lahore.	‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

Risk Statement	Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
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.

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