DRAP issues recall alert for substandard pharma products

ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has issued an immediate recall alert for substandard pharmaceutical products after receiving various complains from the Directorate of Drug Control (DDC) Punjab.The DDC Punjab informed the DRAP that the samples of below mentioned products have been reported as “Substandard”.(i) Amekoran Injection Registration No 053627 Each 2mL contains of Amikacin (as Sulphate) 250mg batch number BK-019 manufactured by M/s Ameer Pharma (Pvt) Ltd, 23-Km, Sheikhupura Road, Lahore following declared “substandard” on the basis of visible particulates.(ii) Ortizin Tablet Registration No 025405 Each film coated tablet contains of Cetirizine dihydrochloride 10mg batch number 24I268manufact ured by M/s Obsons Pharmaceuticals, 209-S, Quaid-e-Azam Industrial Estate, KotLakhpat, Lahore following declared “Substandard” with regards to impurities.(iii) AQUA-P Injection registration No 034290 Sterile water for Injection 5ml batch number P-669 produced by M/s IPRAM International, Plot No 26, St # S.S-3, National Industrial Zone, Rawat following declared “Substandard” on the basis of visible particulate matter.(iv) Injection Dorcip 100ml Registration No 046086 composition of Ciprofloxacin as lactate 2mg/ml batch number DC-121 produced by M/s Trigon Pharmaceuticals (Pvt) Ltd 8-Km, Thokar Raiwind Road, Lahore following declared “Substandard” with regards to visible particulates in injection and Sterility Test.(v) Meclomine Tablet 500mcg Registration No.042601 Each film coated tablet contains of Mecobalamine 500mcg batch number 8482 produced by M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore following declared “Adulterated” as per Section 3(a)(iv) of Drugs Act, 1976.(vi) Meclomine Tablet 500mcg Registration No 042601 each film coated tablet contains of Mecobalamine 500mcg batch umber 8440 M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore following declared “Substandard” on the basis of Physical Description and Assay Testand “Adulterated” as per Section 3(a)(iv) of Drugs Act, 1976.(vii) Injection Neocobal Registration No 042601 Mecobalamine 0.5mg/ml batch number S-2455 made by M/s Pulse Pharmaceuticals (Pvt) Ltd, SuaAasil, Raiwind Road, Lahore following declared “Substandard” on the basis of Assay Test and “Adulterated” as per Drugs Act, 1976.Addressing the National Regulatory Field Force of the DRAP, Provincial Drug Control departments, healthcare professionals, veterinarians, farmers and consumers the DRAP has advised the use of substandard veterinary product can result in therapy failure, increasing the risk of complications and potentially contribute to the development of drug resistance.The regulatory field force of the DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of the mentioned batch of the product from the market.The DRAP has requested to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.Consumers should stop using these product bearing the affected batch numbers. They shall contact their physician or healthcare providers if they have experienced any problem that may be related to using this product.Copyright Business Recorder, 2025

ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has issued an immediate recall alert for substandard pharmaceutical products after receiving various complains from the Directorate of Drug Control (DDC) Punjab. The DDC Punjab informed the DRAP that the samples of below mentioned products have been reported as “Substandard”. (i) Amekoran Injection Registration No 053627 Each 2mL contains of Amikacin (as Sulphate) 250mg batch number BK-019 manufactured by M/s Ameer Pharma (Pvt) Ltd, 23-Km, Sheikhupura Road, Lahore following declared “substandard” on the basis of visible particulates.

(ii) Ortizin Tablet Registration No 025405 Each film coated tablet contains of Cetirizine dihydrochloride 10mg batch number 24I268manufact ured by M/s Obsons Pharmaceuticals, 209-S, Quaid-e-Azam Industrial Estate, KotLakhpat, Lahore following declared “Substandard” with regards to impurities. (iii) AQUA-P Injection registration No 034290 Sterile water for Injection 5ml batch number P-669 produced by M/s IPRAM International, Plot No 26, St # S.S-3, National Industrial Zone, Rawat following declared “Substandard” on the basis of visible particulate matter.

(iv) Injection Dorcip 100ml Registration No 046086 composition of Ciprofloxacin as lactate 2mg/ml batch number DC-121 produced by M/s Trigon Pharmaceuticals (Pvt) Ltd 8-Km, Thokar Raiwind Road, Lahore following declared “Substandard” with regards to visible particulates in injection and Sterility Test. (v) Meclomine Tablet 500mcg Registration No.042601 Each film coated tablet contains of Mecobalamine 500mcg batch number 8482 produced by M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore following declared “Adulterated” as per Section 3(a)(iv) of Drugs Act, 1976.

(vi) Meclomine Tablet 500mcg Registration No 042601 each film coated tablet contains of Mecobalamine 500mcg batch umber 8440 M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore following declared “Substandard” on the basis of Physical Description and Assay Testand “Adulterated” as per Section 3(a)(iv) of Drugs Act, 1976. (vii) Injection Neocobal Registration No 042601 Mecobalamine 0.5mg/ml batch number S-2455 made by M/s Pulse Pharmaceuticals (Pvt) Ltd, SuaAasil, Raiwind Road, Lahore following declared “Substandard” on the basis of Assay Test and “Adulterated” as per Drugs Act, 1976.

Addressing the National Regulatory Field Force of the DRAP, Provincial Drug Control departments, healthcare professionals, veterinarians, farmers and consumers the DRAP has advised the use of substandard veterinary product can result in therapy failure, increasing the risk of complications and potentially contribute to the development of drug resistance. The regulatory field force of the DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of the mentioned batch of the product from the market. The DRAP has requested to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.

Consumers should stop using these product bearing the affected batch numbers. They shall contact their physician or healthcare providers if they have experienced any problem that may be related to using this product. Copyright Business Recorder, 2025.