DRAP Alert No. II/S/08-25-55
Action Date: 18 August 2025
Target Audience:
DRAP’s National Regulatory Field Force
Provincial Drug Control Departments
Hospitals, pharmacies, chemists, and medical stores
Healthcare professionals (physicians, pharmacists, nurses)
General public
Issue:
The Central Drugs Laboratory in Karachi has declared samples of certain drug products as substandard which includes some batches of famila 28F tablets along with other medicines mentioned below.
It is important to note that this is the second time in the month of August, that DRAP has recalled some batches of Famila 28F tablets.
Click here: To see the previous batches of Famila 28F tablets recalled by DRAP
Affected Therapeutic Products:
| Product Name (with Reg. No.) | Batch No. | Reason Declared Substandard | Possible Risks |
|---|---|---|---|
| Famila 28F Tablets – Reg. No. 023941 (Levonorgestrel 0.15 mg, Ethinyl Estradiol 0.03 mg, Ferrous Iron 24.37 mg) | K185 | Failed content uniformity (of levonorgestrel & ethinyl estradiol) & assay of Levonorgestrel | Reduced contraceptive efficacy; hormonal imbalance. |
| Famila 28F Tablets – Reg. No. 023941 | K189 | Failed content uniformity (levonorgestrel & ethinyl estradiol) & assay of Levonorgestrel | Same risks as above |
| Famila 28F Tablets – Reg. No. 023941 | K187 | Failed content uniformity (levonorgestrel & ethinyl estradiol); weight variation of iron; failed assays of Levonorgestrel & Ethinyl Estradiol | Same risks + higher chance of treatment failure in anemic/perimenopausal women due to ; inconsistent iron dosing |
| Famila 28F Tablets – Reg. No. 023941 | K192 | Failed content uniformity & assays of Levonorgestrel + Ethinyl Estradiol | Reduced contraceptive effectiveness; hormonal imbalance |
| Famila 28F Tablets – Reg. No. 023941 | K194 | Failed content uniformity (levonorgestrel & ethinyl estradiol) & assay of Levonorgestrel | Same risks as above |
| Famila 28F Tablets – Reg. No. 023941 | K195 | Failed content uniformity (levonorgestrel & ethinyl estradiol) & assay of Levonorgestrel | Same risks as above |
| Imcomox Suspension – Reg. No. 013756 (Amoxicillin Trihydrate 125 mg/5 ml) | 029 | Low amoxicillin content (failed assay) | Ineffective treatment of infections; risk of treatment failure in infants & children |
| Imcodal Suspension – Reg. No. 013363 (Metronidazole benzoate 64 mg + Furazolidone 25 mg) | 013 | Low furazolidone content (failed assay) | Inadequate treatment of GI infections in children |
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 affected batches of Famila 28F Tablets or imcomox suspension 125mg/5ml or imcodal oral suspenison, 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 (DRAP). (2025, August 18). Recall alert: Drug products declared substandard by Central Drugs Laboratory Karachi [Safety alert]. Drug Regulatory Authority of Pakistan. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-drug-products-declared-substandard-by-central-drugs-laboratory-karachi/
