DRAP Recall Alert No.: I/S/09-25-59
Date of Action: 10th September 2025
Intended Audience:
Regulatory Field Force of DRAP and Provincial Drug Control Departments
Healthcare Professionals
Pharmacies and Medical Stores
Problem Statement
Provincial Drug Testing Laboratories have notified the Drug Regulatory Authority of Pakistan (DRAP) that the following therapeutic goods have been declared “Spurious”, “Falsified” or “Substandard”. These medicines bear packaging that falsely claims to be manufactured by licensed pharmaceutical companies, thus posing a serious public health risk. Details are provided below.
Therapeutic Goods Affected
Tablet ONSET-8 (Reg. # 025989)
Composition: Each tablet contains Ondansetron HCl 8 mg.
Batch No.: 447
Purported Manufacturer: Pharmedic Laboratories (Pvt.) Ltd., Lahore (DML# 000228) 16Km Multan road lahore.
Remarks: Declared “Spurious” under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
Capsule Nexum 40 mg (Reg. # 033891)
Composition: Each capsule contains ENTERIC-COATED PELLETS OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE EQUIVALENT TO ESOMPERAZOLE 40 MG)
Batch No.: C02085
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., Karachi.
Remarks: Declared “Spurious” under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976..
Capsule Maxflow-D (Reg. # 033891)
Composition: Each capsule contains Extended release pellets of Tamsulosin HCl eq. to Tamsulosin HCl …… 0.4mg.
Batch No.: QM375
Purported Manufacturer: CCL Pharmaceuticals (Pvt.) Ltd., Lahore (DML# 000052).
Remarks: ‘Spurious with regard to Dutasteride, misbranded with regard to labelling & substandard on basis of dissolution test and assay of tamsulosin HCl’. under clause (i) and (ii) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
Capsule Azomax 250 mg:
Composition: Each capsule contains Azithromycin 250 mg.
Batch No.: C3193
Purported Manufacturer: AGP Ltd., Karachi (DML#000348).
Remarks: Declared “Spurious” under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
Tablet Rigix 10 mg:
Composition: Each film-coated tablet contains Cetirizine 10 mg.
Batch No.: C3905 & C3362
Purported Manufacturer: AGP Ltd., Karachi (DML# 000348). (Recovered from unauthorized person / paddler).
Remarks: Declared “Spurious” due to mismatch in batch number between carton and blister, under clause (i) of subsection (z-b). The unit carton bears batch # C3905 while blister bears Batch # C3362.
Tablet Fexet 120 mg:
Composition: Each tablet contains Fexofenadine 120 mg.
Batch No.: F26018
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., Karachi.
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Capsule Zetro 250 mg:
Composition: Each capsule contains Azithromycin 250 mg.
Batch No.: 247C21
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., Karachi. (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Duphaston:
Composition: Each tablet contains Dydrogesterone 10 mg.
Batch No.: 241476
Purported Manufacturer: Highnoon Laboratories Ltd., Lahore (DML# 000155). (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Danzen DS:
Composition: Each tablet contains Serratiopeptidase 10 mg (20,000 units of Serratiopeptidase).
Batch No.: 3602
Purported Manufacturer: Helix Pharma (Pvt.) Ltd., Karachi (DML# 000030). (Recovered from unauthorized person / paddler).
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Terbisil 250 mg:
Composition: Each tablet contains Terbinafine 250 mg.
Batch No.: 473
Purported Manufacturer: Saffron Pharmaceuticals (Pvt.) Ltd., Lahore (DML# 000616). (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Terbisil 250 mg:
Composition: Each tablet contains Terbinafine 250 mg.
Batch No.: 473
Purported Manufacturer: Helix Pharma (Pvt.) Ltd., Karachi (DML# 000030). (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Azomax 500 mg:
Composition: Each tablet contains Azithromycin 500 mg.
Batch No.: C3670
Purported Manufacturer: AGP Ltd., Karachi (DML# 000348).
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Prism 10 mg:
Composition: Each tablet contains Escitalopram 10 mg.
Batch No.: 25PR02
Purported Manufacturer: Friends Pharma (Pvt.) Ltd., Lahore (DML# 000531). (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Capsule Gabica 300 mg:
Composition: Each capsule contains Pregabalin 300 mg.
Batch No.: 427C27
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., Karachi. (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Tablet Ativan 2 mg:
Composition: Each tablet contains Lorazepam 2 mg.
Batch No.: 17C7019
Purported Manufacturer: Pfizer Pakistan Ltd., Karachi. (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious” under clause (i) of subsection (z-b).
Injection ONSET 4 ml:
Composition: Each 4 ml injection contains Ondansetron 2 mg/ml.
Batch No.: 829
Purported Manufacturer: Pharmedic Laboratories (Pvt.) Ltd., Lahore (DML# 000228). (Recovered from unauthorized person / paddler)
Remarks: Declared “Spurious & Substandard” under clause (i) of subsection (z-b).
Risk Statement
All the products listed above are confirmed falsified/spurious because their packaging falsely claims manufacture by licensed companies, whereas they are not. Laboratory results show absence of active pharmaceutical ingredients, meaning no therapeutic effect. Such falsified drugs pose serious public health risks, including treatment failure, disease progression, and life-threatening outcomes—especially for patients depending on these medicines for essential therapy. The public is strongly advised not to use these products and to report any suspicious medicines to DRAP immediately.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
Guidance for Healthcare Professionals
DRAP advises healthcare professionals to remain vigilant in pharmacies, healthcare facilities, and supply chains potentially affected by these products. Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
Reference:
Drug Regulatory Authority of Pakistan. (2025, September 10). Rapid alert: Spurious / falsified medicines declared by provincial laboratories (DRAP Alert No. I/S/09-25-59). Drug Regulatory Authority of Pakistan. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/rapid-alert-spurious-falsified-declared-by-provincial-laboratories/
