DRAP issues immediate recall alert for substandard pharma products

ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has issued an immediate recall alert for a number of substandard pharmaceutical products after receiving various complains from the Directorate of Drug Control (DDC) Punjab.

The DDC Punjab has informed the DRAP that the samples of below mentioned products have been reported as “Substandard”.

(i) Tablet AMLO Shine 5mg, Registration No 062420; each tablet contains of Amlodipine as besylate 5m batch number 7974 manufactured by M/s Sunshine Pharmaceuticals, Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala. (ii) Powder for Injection Tyclan Registration No 087923; each vial contains of Teicoplanin B.P 400mg batch number TL-011 manufactured by M/s MTI Medical (Pvt) Ltd, 586-587, Sundar Industrial Estate, Lahore. (iii) Injection Linco-HCL Registration No 023729; each 2ml ampoule contains of Lincomycin as HCl 600mg batch number LN-042 produced by M/s Trigon Pharmaceuticals (Pvt) Ltd 8-Km, Thokar Raiwind Road, Lahore. (iv) Safemed Infusion Registration No 045824; each 100ml vial contains of Metronidazole 500mg batch number SJU-1724 produced by M/s Ahad International Pharmaceuticals Ltd 13-Km, Gomal University, Multan Road Dera Ismail Khan. (vi) Ketamine hydrochloride Injection; each ml contains of Ketamine hydrochloride equaliant to ketamine 50mg batch number GN1359 produced by M/s KWALITY Pharmaceuticals Ltd Nag Kalan, Majitha Road, Amristsar 143 601 (India).

According to DRAP, the use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immuno compromised individuals, as well as pediatric and geriatric population.

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