Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/09-25-69 |
| Action Date | 15 September, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1 | SN DOL Suspension 60ml. Each 5ml contains: Paracetamol ……… 120 mg | 917 | M/s SNB Pharma (Pvt) Ltd. Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 2 | SALBOVENT Oral syrup 60ml Each 5ml contains Salbutamol (as sulphate) .. 2mg | L25D52 | M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 3 | RESGYL Suspension 60 ml Each 5ml contains Benzoyl Metronidazole equivalent to Metronidazole ………… 200 mg | 4E566 | M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 4 | Tablet Daisy 10 mg Each film coated tablet contains Cetirizine Dihydrochloride USP ………………………….10mg | 258084 & 258085 | M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537) | ‘Substandard’ on the basis of Test for impurities (Organic impurities). |
| 5 | Colchis Capsules Each Hard Gelatin Capsule contains: Thiocolchicoside ……….4 mg | 15 | M/s Akson Pharmaceuticals (Pvt) Ltd. Plot No. 9B-1 & 2 Sector D-1 Old Industrial Estate Mirpur Azad Kashmir. (DML # 000486) | ‘Substandard’ on the basis of Assay and uniformity of weight. |
| 6 | AQUA-P Injection (Sterile Water for Injection 5mL) | P-676 P-677 | M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551) | Drug Testing Laboratory, Lahore declared the sample as ‘substandard’ quality on the basis of the result of test for bacterial endotoxins. |
| 7 | Sterile Water for Injection 10ml Each Glass Ampoule contains: WFI …………………. 10mL | 084L24 | M/s Brookes Pharma (Pvt) Ltd. Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275) | ‘Substandard’ on the basis of Bacterial Endotoxins Test. |
| 8 | Sterile Water for injection 5 ml Each Glass Ampoule contains: WFI …………………. 5 ml | 130 | M/s Wilshire Laboratories (Pvt) Ltd. 124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232) | ‘Substandard’ on the basis of Bacterial Endotoxins Test. |
| Risk Statement: | The above drug products have been declared substandard / adulterated due to toxic impurities, undeclared ingredients, assay failures, sterility issues, and bacterial endotoxins. Their use may cause treatment failure, harmful side effects, or serious health risks including infections and toxicity. Children, elderly, hospitalized, and immunocompromised patients are at greater risk. The public and healthcare providers are advised to stop use and return the affected batches immediately. |
| 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. |