DRAP RECALLS-BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
Target Audience:
DRAP’s national regulatory field force and provincial drug control departments
Pharmacists and chemists in distribution, pharmacies, and medical stores
Healthcare professionals (physicians, pharmacists, nurses)
General public
Issue Summary:
The Central Drugs Laboratory in Karachi notified the Drug Regulatory Authority of Pakistan that certain batches of Famila 28F Tablets (Reg. No. 023941), produced by M/s Zafa Pharmaceuticals Lab (Pvt) Ltd. (DML No. 000490), have been found to be substandard following laboratory testing.
Defective Batches & Test Failures:
K217: Fails in levonorgestrel and ethinyl estradiol content uniformity, and iron weight variation test
K177: Fails in levonorgestrel and ethinyl estradiol content uniformity, iron weight variation, and levonorgestrel assay test
K203, K207: Iron weight variation test failures
K184, K190, K191: Content uniformity of levonorgestrel & ethinyl estradiol and levonorgestrel assay test failures
K182: Fails in content uniformity test of levonorgestrel and ethinyl estradiol and iron weight variation test
K199, K205: Ethinyl estradiol content uniformity and iron weight variation test
K204: Content uniformity failures for levonorgestrel and ethinyl estradiol
Risk Statement:
These quality defects may reduce contraceptive effectiveness, cause hormonal imbalance, and lead to inconsistent iron intake, potentially resulting in therapy failure and adverse health outcomes.
Actions Initiated:
DRAP and provincial regulatory teams are conducting market inspections to locate and remove the affected batches from circulation.
Pharmacists, chemists, and distributors must immediately halt distribution of these batches, quarantine them, and arrange returns to suppliers.
Distributors and pharmacies should remain vigilant and report any suspected batch via DRAP’s online reporting form or by email at gsms@dra.gov.pk.
Surveillance efforts have been heightened across all regions to support the recall.
Guidance for Healthcare Professionals:
Maintain heightened vigilance throughout institutional and supply chain procurement processes. Any quality or adverse events linked to these batches should be filed with the National Pharmacovigilance Centre via the official reporting form or online portal.
Advice for Consumers:
If you have Famila 28F Tablets from the affected batches, please stop using them immediately. Consult a healthcare provider if you have experienced any related health issues. Always purchase medicines from licensed outlets and inspect products for authenticity and integrity. When in doubt, seek advice from a pharmacist.
Reference:
Drug Regulatory Authority of Pakistan. (2025, August 4). Recall alert – Batches of “Tablet Famila 28F” declared substandard by Central Drugs Laboratory Karachi. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-batches-of-tablet-famila-28f-declared-substandard-by-central-drugs-laboratory-karachi/
