DRAP issues alert as GSK voluntarily recalls Amoxil batch

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has issued an alert to recall Amoxil Suspension and Amoxil Forte Suspension due to quality defect.

GlaxoSmithKline (GSK) Pakistan has initiated a voluntary recall of multiple batches of its widely used antibiotics — Amoxil Suspension and Amoxil Forte Suspension — following a quality concern related to defective induction seals on bottles, the Drug Regulatory Authority of Pakistan (DRAP) announced.

The company notified DRAP that dozens of batches of these products, manufactured at its facility in Karachi, may have compromised induction seals — a packaging defect that can affect the integrity of the medicine, especially under certain storage or usage conditions.

The recall covers more than 150 batch numbers including: 7W9V, 8L5H, 9S5D, 9X3E, AH9Y, AP2M, AS5B, AT7M, C25W, C37E, CD6T, DL5L, EE9R, FA8M, FB9C, FE9X, and many others. A full list is available here.

DRAP, in coordination with provincial drug control departments, has directed its regulatory field force to conduct immediate market surveys to detect and remove the affected products from pharmacies and distributors across the country. Moreover, All pharmacists and chemists at wholesale and retail outlets are instructed to immediately stop the sale and distribution of the listed batches.

“Consumers are also advised to stop using Amoxil products with the affected batch numbers, and consult their doctor or healthcare provider if they have experienced any adverse effects potentially linked to the product”, DRAP stated. “Report any side effects or quality issues to the National Pharmacovigilance Centre (NPC) using DRAP’s Adverse Event Reporting Form or online system”.

The decision to recall these products has been made as a precautionary measure, according to DRAP.