DO NOT use these syringes, DRAP issues alert

The Drug Regulator Authority of Pakistan (DRAP) has issued a recall alert for two batches of medical syringes after they were declared substandard following laboratory testing.

The DRAP issued the alert following the Central Drugs Laboratory (CDL) in Karachi found that the products had failed critical quality tests.

The affected products are a batch of BD 10 mL Syringes (MDMR-0000035) Batch No. 5349764, and Accuject Auto-Disable Syringe 5 mL (MDMR-000507) Batch No. S502E26, manufactured by Faiz Surgical and Medical Industries (Pvt.) Ltd. in Lahore.

According to DRAP, the BD syringe batch failed an absorbance test, suggesting the presence of excessive extractable substances that could affect the product’s safety and quality during medical use.

The Accuject syringe batch also failed a sterility test, raising concerns about possible microbial contamination.

The regulator said using the affected syringes could increase the risk of infection, including potentially serious systemic infections.

DRAP has instructed its regulatory field teams and provincial drug control authorities to conduct immediate market inspections and remove the affected batches from circulation.

Manufacturers, importers, and distributors have also been directed to recall the products in line with regulatory requirements.

Healthcare professionals have been advised to check their inventories for the affected batches and report any adverse reactions or suspected quality issues to DRAP’s National Pharmacovigilance Centre.

Pharmacies and medical stores have also been instructed to stop supplying the affected products immediately, quarantine any remaining stock, and return it to suppliers or manufacturers.