DRAP orders immediate recall of GSK syrups over safety concerns

The Drug Regulatory Authority of Pakistan (DRAP) has issued an urgent alert directing the immediate recall of two key pharmaceutical syrups produced by GSK due to quality concerns, including defects in bottle caps and seals, 24NewsHD TV reported on Tuesday. 

According to the official alert released by DRAP, Amoxil Forte 250mg and Amoxil Forte 125mg syrups—widely used to treat infections such as typhoid and meningitis—are being withdrawn from pharmacies and hospitals across Pakistan after multiple defective batches were identified.

The authority has instructed the recall of 58 batches of Amoxil Forte 250mg and 111 batches of Amoxil Forte 125mg. 

These batches were found to have packaging defects, specifically involving the caps and sealing mechanisms of the bottles.

DRAP stated that GSK itself notified the regulatory body of the issues, prompting swift action to mitigate potential health risks.

 “We immediately initiated corrective measures following the manufacturer’s disclosure,” said a DRAP official in the alert.

To prevent any harm to the public, DRAP has ordered all hospitals, pharmacies, and distributors to identify and return the affected batches without delay. 

Likewise, DRAP has taken decisive action against substandard contraceptive medicines produced by Zafa Pharmaceuticals, declaring 11 batches of "Famla 28F" tablets unfit for public use.

The Central Drugs Laboratory in Karachi conducted detailed testing and determined that these 11 batches of Famla 28F tablets failed to meet required quality standards.

As a result, DRAP has issued immediate instructions to remove these products from the market.

The batches found to be non-compliant with quality regulations include:

Batch numbers: 217, 177, 207, 203, 184, 190, 191, 182, 199, 205, and 204

Famla 28F is a widely used oral contraceptive, and the discovery of quality defects has raised public health concerns, particularly regarding the efficacy and safety of these tablets.

DRAP confirmed that the defective samples were identified during routine quality surveillance and laboratory testing.

 "These batches have been officially declared substandard and must be withdrawn from all retail and medical outlets without delay," the authority stated.

In light of this, DRAP has directed all hospitals, pharmacies, and healthcare institutions to urgently identify and return the specified batches.