Recall Alert
| DRAP Alert No | No I/S/01-25-03 |
| Action Date | 2nd January, 2025. |
| Target Audience | – National Regulatory Field Force of DRAP and Provincial Drug Control Departments. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Federal Inspector of Drugs, Peshawar collected the samples of Cefradin Capsules and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 3591 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as of Substandard quality.DDCP PV Lahore has informed DRAP regarding the recall of the following batches of the mentioned products: |
Therapeutic Good(s) Affected: –
| Sr.No. | Product Names | Composition | Manufactured by | Test Results |
| 1. | Cefradin Capsule Reg. No. 036991 | Cefradine (250mg/Capsule) Batch No. 3591 Mfg date: 05/24 Expiry date: 05/26 | M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar. | Substandard |
| Risk Statement: | The cefradine capsules have been identified as substandard due to deviations in weight variation, which could impact their efficacy, safety, and quality. If the weight of the capsules is not within the prescribed limits, there is a risk of inaccurate dosing. As a result, patients may not receive the correct amount of medication, which could lead to therapeutic failure, side effects, or the development of resistance. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market. – The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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, and 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 the product bearing the affected batch number(s). They should 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. |