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RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCTS

Ahsan Hafiz Recall Alerts
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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert NoNo I/S/08-25-56
Action Date20th August, 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’. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#Product NameBatch No.Purported ManufacturerRemarks
1 Brexin Tablet Each tablet contains: Piroxicam-β-Cyclodextrine (Lyophilized) e.q to Piroxicam……20mg1192087Purported 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.
 2Tablet Zetro 500mg (Reg. # 053120)   Each film coated tablet contains: Azithromycin (as dihydrate) ………………….500 mg  F18031Purported 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.  7F4WPurported 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.
 4Tablet TONOFLEX-P   Each Film Coated Tablet Contains: Tramadol HCl …… 37.5 mg Paracetamol ……… 325 mg  KFM145Purported 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.
 5Tablet EFASTON   Each film coated tablet contains Dydrogesterone …… 10 mg41160Purported 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.
 6Capsule Gabica 300 mg   Each Capsule contains: Pregabalin ……… 300 mg403C27Purported 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.
 7Imcomox Capsule   Each Capsule Contains: Amoxycillin trihydrate eq. to Amoxycillin (U.S.P) …. 500mg  08Purported 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.
 8Omnidol NU Tablet   Each uncoated tablet contains: Paracetamol …….500mg Caffeine …………….65 mg1220Purported 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.
 9CAPSULE CEFSPAN 400 mg   Each capsule contains: Cefixime………400mgF0580Purported 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.
 10CAPSULE ICON 100 mg Each capsule contains: Itraconazole pellets eq. To itraconazole 100 mg  241694Purported 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.
 11Tablet NOVIDAT Each film coated tablet contains:  Ciprofloxacin Hydrochloride eq. to Ciprofloxacin 500mgFIM147Purported 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 StatementAll 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 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 – DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/08-25-55
Action Date18 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 NameBatch No.ManufacturersRemarks
1.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K185M/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)		K189M/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)		K187M/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)		K192M/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)		K194M/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)		K195M/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)029M/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)		013M/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 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.

    RAPID ALERT – CRACKDOWN AGAINST UNLICENSED/UNAUTHORIZED MANUFACTURERS

    Ahsan Hafiz Recall Alerts
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    Rapid Alert

    CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

    DRAP Alert NoNo I/S/08-25-54
    Action Date11th August, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementThe 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 NameBatch No.Purported ManufacturerRemarks
    1Missron Tablet   Each Tablet contains Dydrogesterone ……. 10mg  48022M/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.
    2Quttefol OD tablets   Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcgQL-001M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, LahoreDrug 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.
    3Depasrone Tablets   Each Tablet contains Dydrogesterone ……. 10mg  2406M/s Alpine Laboratories, Plot A-41, S.I.T.E., KarachiDrug 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.
    4Dropha Tablets   Each Tablet contains Dydrogesterone ……. 10mg  DRP-0004M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, KarachiDrug 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 StatementAll 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 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.

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

    Ahsan Hafiz Recall Alerts

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    DRAP Alert NoNo II/V/08-25-53
    Action Date05th 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 NameManufacturersBatch No.
    1Amoxil 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  
     2Amoxil 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 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 – BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

      Ahsan Hafiz Recall Alerts

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      DRAP Alert NoNo II/S/08-25-52
      Action Date04 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 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: Voluntary Recall of 36 Batches of Motival Tablets (Reg # 004539) Manufactured by M/s GSK Pakistan Limited, Karachi.

        Muhammad Ayub Naveed Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/02-25-18
        Action Date18th February 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 firm M/s GSK Pakistan Limited, Karachi has notified Drug Regulatory Authority of Pakistan that they have initiated voluntary recall of 36 batches of Motival Tablets due to the detection of nitrosamine impurity, N-nitroso nortriptyline. Moreover, the firm has reported that it has ceased the manufacture and release of Motival Tablets. The details of the recalled product lots are as follows:

        Therapeutic Goods (s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Motival Tablets
        5 × 20’s
         
        (Reg # 004539)
         

        		Nortiptyline as HCl 10mg + Fluphenazine HCl 0.5mg
        Batch No.
        9P8L, A95S, A95Y, AN5N, AN5P, AN5R, AN5T, CK7G, CK7H, DT7B, DT7D, DL8J, DT7C, H58X, H58Y, H59A, J77W, J77V, K36F, K36E, KD6N, KD6P, M32F, ME8N, ME8R, R47H, R47K, R47L, SA7F, SA7G, SA6V, WM8R, WM8T, WM8U, YB7A, YB7B.        		M/s. GSK Pakistan Limited, Plot # 5, Sector 21, Korangi Industrial Area, Karachi.
        Risk Statement:The risk of nitrosamine impurity in nortriptyline, like other pharmaceutical products, is a broader concern that has become more prominent after several incidents. These impurities are believed to have carcinogenic potential in certain situations.
        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 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.

          Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

          Muhammad Ayub Naveed Uncategorized
          Download

          Rapid Alert

          DRAP Alert NoNo  I/S/02-25-18
          Action Date17th February, 2025
          Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
          2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
          3. General Public
          Problem StatementDrug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below:

          The product identification details are as under:

          Therapeutic goods affected:

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          Evosef 250mg capsule
          (Cephradine 250mg)          		HF-001Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, LahoreSpurious. Cephradine not identified
          Mirzpan Suspension 100mg/5ml
          (Cefixime)          		0008M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Cefixime not identified
          Mirzolam Tablet 0.5mg (Alprazolam)0007M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Alprazolam not identified
          Bromalax Tablet 3mg (Bromazepam)B-01M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore.Spurious, Bromazepam not identified
          Malixime Suspension 200mg/5ml
          (Cefixime)          		78011M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi.Spurious, Cefixime not identified
          Lexopam Tablet 3mg (Bromazepam)B-01M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar.Spurious, Bromazepam not identified
          Zionex Tablet 0.5mg (Alprazolam)0032M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi.Spurious, Alprazolam not identified
          Tramaking-225 Mega tablet 225mg
          (Tramadol HCl)          		TRD2002Name of Manufacturer not mentioned.Spurious
          Alcoxime Suspension 100mg/5ml
          (Cefixime)          		A2011M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan.Spurious, Cefixime not identified

          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 InitiatedThe Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
          Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

          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 at this link.
          Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

          Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

          Asad Ullah Events , , , , ,
          Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

          National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.

          The workshop focused on the following key objectives:

          1. Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
          2. Emphasizing the need and importance of Recall and Rapid Alert System.
          3. Training and building capacity of all the participants.
          4. Enhancing coordination and communication with provincial governments and related departments.
          5. Safe disposal system of SF products
          6. Improvement in DRAP’s guidelines and harmonization with International best practices.

          Risk Communication flow chart for handling SF threats

          Core Activities and Topics Covered

          1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.

          2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.

          3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.

          4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion. 

          5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.

          6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets. 

          7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.

          8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.  

          Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

          Asad Ullah Recall Alerts , , , ,

          Recall Alert

          DRAP Alert NoNoI/S/20-23-21
          Action Date20th April 2023
          Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
          2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
          3. General Public
          Product(s) Affected Spadix 4mL Injection
          Composition: Phloroglucinol and Trimethylphloroglucinol
          Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi
          Batch No. 570
          Problem / Issue A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from market.
          Risk StatementDrug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users
          (i) Anaphylactic shock in patients which may lead to death of patient
          (ii) Skin rashes, itching, difficulty in breathing
          (iii) Sub optimal to no therapeutic effect for indicated medical treatment.
          Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market.

          -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company.

          -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

          -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using 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 this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

          -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
            Recall-of-Spadix-InjectinDownload

            Recall Alert: Drug Product; Hydralazine 25mg Tablets (Batch # 257) by M/s Zafa Pharmaceuticals (Pvt) Ltd, Karachi .

            Asad Ullah Recall Alerts ,

            Recall Alert

            DRAP Alert NoNoI/S/02-23-12
            Action Date21st February 2023.
            Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
            2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
            3. General Public
            Product(s) Affected Hydralazine 25mg Tablets
            Active Ingredient(s): Hydralazine
            Company: M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi.
            Batch No. 257
            Manufacturing Date: 10-2022
            Expiry Date: 10-2027
            Problem / Issue CDL Karachi has declared the batch No. 257 of Hydralazine 25mg Tablets, manufactured by M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
            Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

            -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company.

            -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

            -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using 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 this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

            -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
              Hydralazine-25mg-Tab-Zafa-Recall-AlertDownload