DRAP recalls substandard pharmaceutical products after complaints

Regulatory authority issues recall for AMLO Shine, Tyclan, Linco-HCL, Safemed Infusion, and Ketamine injections

The Drug Regulatory Authority of Pakistan (DRAP) has issued an immediate recall for several pharmaceutical products after receiving complaints from the Directorate of Drug Control (DDC) Punjab regarding their substandard quality.

According to a news report, the recalled products include AMLO Shine 5mg tablet (Registration No. 062420), manufactured by M/s Sunshine Pharmaceuticals, Gujranwala. Each tablet contains Amlodipine as besylate 5mg (Batch No. 7974). 

Another recalled product is Tyclan 400mg Powder for Injection (Registration No. 087923), produced by M/s MTI Medical (Pvt) Ltd, Lahore. Each vial contains Teicoplanin B.P 400mg (Batch No. TL-011). 

Additionally, Linco-HCL 600mg Injection (Registration No. 023729), manufactured by M/s Trigon Pharmaceuticals (Pvt) Ltd, Lahore, is part of the recall. Each 2ml ampoule contains Lincomycin as HCl 600mg (Batch No. LN-042). Safemed Infusion 500mg (Registration No. 045824), produced by M/s Ahad International Pharmaceuticals Ltd, Dera Ismail Khan, is also recalled. Each 100ml vial contains Metronidazole 500mg (Batch No. SJU-1724). 

Ketamine Hydrochloride Injection 50mg (Batch No. GN1359), manufactured by M/s Kwality Pharmaceuticals Ltd, Amritsar, India, is also being recalled. Each 1ml contains Ketamine hydrochloride equivalent to ketamine 50mg.

DRAP emphasised that the use of substandard products could lead to therapy failure and increase the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, children, and the elderly. 

The authority has urged the healthcare providers and consumers to ensure that these products are removed from circulation to prevent potential harm.

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