DRAP Recalls Multiple Batches of Famila-28F Over Quality Concerns

The Drug Regulatory Authority of Pakistan (DRAP) has issued an urgent recall of multiple batches of Famila-28F contraceptive tablets, manufactured by Zafa Pharmaceuticals, after laboratory tests revealed serious quality issues.

According to the Central Drugs Laboratory Karachi, several batches failed critical tests for content uniformity of Levonorgestrel and Ethinyl Estradiol, as well as weight variation in the iron component. These deficiencies could lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, posing significant health risks.

The affected batches include:

  • K217, K177, K203, K207, K184, K190, K191, K182, K199, K205, K204 Each failed one or more tests related to hormonal content or iron dosage.

DRAP has directed its national regulatory field force, provincial drug control departments, and healthcare professionals to:

  • Immediately remove affected products from the market
  • Quarantine and return remaining stock to suppliers
  • Report any suspected batches via DRAP’s online form or email

Pharmacists, chemists, and healthcare providers have been urged to check inventories and stop distribution of the listed batches. Consumers are advised to discontinue use and consult their physicians if they’ve experienced any adverse effects.

This recall underscores the need for stricter quality control and regulatory vigilance in Pakistan’s pharmaceutical sector to safeguard public health.

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