DRAP Initiates Nationwide Recall of Amoxil Forte Suspension Over Safety Concerns

DRAP Orders Immediate Recall of Amoxil Forte Suspension Amid Safety Risks

In a decisive move to safeguard public health, the Drug Regulatory Authority of Pakistan (DRAP) has issued an urgent recall of multiple batches of Amoxil Forte Suspension, a widely used antibiotic manufactured by GlaxoSmithKline (GSK) Pakistan. The recall was prompted by the discovery of defective induction seals on the product’s packaging, which could compromise the medicine’s integrity and efficacy.

What Triggered the Recall?

GSK Pakistan voluntarily notified DRAP about the packaging defect, specifically involving the induction seals of Amoxil Forte Suspension 250mg and 125mg bottles. These defects pose potential risks under certain storage or usage conditions, prompting DRAP to act swiftly and issue a nationwide alert.

The recall affects over 150 batches of the product, which are commonly prescribed for bacterial infections such as typhoid, respiratory tract infections, and meningitis.

DRAP’s Response and Action Plan

DRAP has directed its regulatory field force and provincial drug control departments to:

• Conduct immediate market surveys to identify and remove affected batches
• Increase surveillance across pharmacies, hospitals, and distributors
• Ensure proper quarantine and return of defective stock to the manufacturer

Healthcare professionals, including pharmacists and physicians, have been advised to halt the supply of the recalled products and verify their inventory for affected batch numbers.

Advice for Pharmacies and Healthcare Providers

Pharmacies and medical stores are instructed to:

• Immediately check stock for affected batches
• Stop dispensing the recalled products
• Quarantine and return defective items to suppliers

Healthcare providers are urged to remain vigilant and report any adverse reactions or product anomalies to DRAP for further investigation.

Ensuring Pharmaceutical Safety in Pakistan

This recall underscores the importance of stringent quality control and proactive regulatory oversight in Pakistan’s pharmaceutical sector. DRAP’s rapid response reflects its commitment to protecting consumers from potentially harmful therapeutic goods.

For more updates on pharmaceutical safety, drug recalls, and healthcare regulations, explore related articles on medicine safety protocols and regulatory compliance in Pakistan.