Recall Alert
| DRAP Alert No | No II/S/09-25-58 |
| Action Date | 10 September, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K159 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K159) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & weight variation of Ferrous Iron. |
| 2. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K198 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K198) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel & Ethinyl Estradiol. |
| 3. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K196 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K196) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel. |
| 4. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K197 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | Central Drugs Laboratory declared the Famila 28F Tablets (Batch # K197) as ‘Substandard’ on the basis of out of specification results for the test of content uniformity of Levonorgestrel & Ethinyl Estradiol, weight variation of Ferrous Iron & Assay of Levonorgestrel & Ethinyl Estradiol. |
| Risk Statement: | The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |