Recall Alert
| DRAP Alert No | No I/S/01-25-11 |
| Action Date | 16th January 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 | The Senior Drug Inspector, District Health Office, Quetta collected the samples of Infusion Safemed and sent them for test and analysis. The Provincial Drug Testing Laboratory, Quetta, has declared the following batch of Infusion Safemed, manufactured by M/s. Ahad International Pharmaceuticals Ltd., Sheikhupura, as Adulterated. The injection was found to contain foreign matter, which is visible to the naked eye: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Safemed 500mg Infusion Reg. No. 045824 | Metronidazole | Batch No. SJU-0824 | M/s. Ahad International Pharmaceuticals Ltd. 13-Km, Gomal University, Multan Road Dera Ismail Khan |
| Risk Statement: | An injectable product that contains foreign matter is considered adulterated and may compromise the standard quality of the drug, as it may not be sterile. Sterility is a fundamental quality attribute for all injectable drugs. The presence of adulterated material can lead to serious adverse reactions in patients, including, but not limited to, the following: (i) Anaphylactic shock, which can be fatal. (ii) Skin rashes, itching, and difficulty in breathing. (iii) Suboptimal or no therapeutic effect for the intended medical treatment. |
| 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 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/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. |