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RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert NoNo I/S/09-25-60
Action Date10th September, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate 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 NameBatch No.Purported ManufacturerRemarks
 1PAYODEN Solution 60mL
Each 100ml contains: Povidone-Iodine.10.0g eq. to 1.0g available Iodine (1%w/v)		006Purported 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 StatementPurported 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 InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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
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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert NoNo I/S/09-25-59
Action Date10th September, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug 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 NameBatch No.Purported ManufacturerRemarks
1TABLET ONSET-8 (REG # 025989)   Each Tablet Contains: ondansetron HCl eq. To ondansetron 8 mg)  447Purported 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.  
2Capsule Nexum (Reg # 033891)   EACH Capsule contains: ENTERIC-COATED PELLETS OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE EQUIVALENT TO ESOMPERAZOLE 40 MG)C02085Purported 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.  
3Capsule Maxflow -D (Reg # 033891)   EACH Capsule contains: Extended release pellets of Tamsulosin HCl eq. to Tamsulosin HCl …… 0.4mgQM375Purported 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’.  
4Capsule Azomax 250 mg   Each Capsule contains: Azithromycin (as di-hydrate) …………………… 250 mg  C3193Purported 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)
5Tablet Rigix  Each film coated tablet contains: Cetirizine hydrochloride…….10mg  C3905 C3362Purported 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)  
6Fexet Tablet 120mg  Each film coated tablet contains: Fexofenadine hydrochloride. ….120mg  F26018Purported 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)
7Capsule Zetro 250 mg Each Capsule contains: Azithromycin (as dihydrate) ……..250 mg247C21Purported 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)
8Tablet Duphaston Each film coated tablet contains: Dydrogesterone … 10mg241476Purported 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)  
9Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase 10 mg (20,000 units of Serratiopeptidase)3602Purported 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)  
10Tablet Terbisil Each Tablet contains: Terbinafine (as HCl)  250 mg473Purported 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)
11Tablet Terbisil Each Tablet contains: Terbinafine (as HCl)  250 mg473Purported 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)
12Tablet Azomax 500 mg Each film coated tablet contains : Azithromycin (as di-hydrate) ……..500 mgC3670Purported 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)
13Tablet Prism 10 mg Each tablet contains: Escitalopram oxalate eq. to escitalopram ……. 10 mg25PR02Purported 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)
14Capsule Gabica 300mg Pregabalin l00mg427C27Purported 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)
15Tablet Ativan 2 mg Each tablet contains: Lorazepam …… 2 mg 17C7019Purported 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)
16Injection ONSET 4 ml   ondansetron HCl eq. To ondansetron 2mg/ml)  829Purported 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 StatementAll 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 InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

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Recall Alert

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DRAP Alert NoNo II/S/09-25-58
Action Date10 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 NameBatch No.ManufacturersRemarks
1.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K159M/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)		K198M/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 ProfessionalsDRAP 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

    Recall Alert

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    DRAP Alert NoNo I/S/09-25-57
    Action Date09 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 NameBatch No.ManufacturersRemarks
    1.Anarob Infusion Each 100 ml of infusion contains: Metronidazole …500 mgH24219M/s Vision Pharmaceuticals (Pvt.) Ltd, (DML # 000517) Plot No. 22-23 Industrial Triangle Kahuta Road IslamabadCentral 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 ProfessionalsDRAP 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.

      Directive for Submission of Antimicrobial Batch Production and Import Data in DRIS

      Yasir Mahmood Pharmacovigilance

      Registration holders of Pharmaceutical Products for human and veterinary use (manufacturers and importers) are directed to submit antimicrobials batch production / Import data (finished formulations) for use within Pakistan regularly in DRIS. DRAP will be analyzing yearly data for regulatory purposes. The data is critical for use in implementing Antimicrobial Stewardship Policies to combat AMR in Pakistan.