Recall Alert
| DRAP Alert No | No I/S/11-24-50 |
| Action Date | 29th November, 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | TDDCP PV Lahore and Secretary PQCB Quetta has informed DRAP regarding recall of following batches of mentioned products: |
Therapeutic Good(s) Affected: –
| Sr.No. | Product Names | Composition | Manufactured by | Test Results |
| 1. | Infusion Zeesol-5 1000 mL Reg# 016611 | Dextrose Anhydrous 50 g/ 1000mL | Shazeb Pharmaceutical Industries Limited Hazara Trunk Road, Sarai Gadaee, District Haripur, K.P.K Pakistan | Substandard on the basis of Bacterial Endotoxin |
| 2. | Sterile Water for Injection 5 mL Reg# 062671 | Sterile Water for Injection | Fynk Pharmaceuticals 19-KM. G.T. Road, Kalashah Kaku, Lahore | Substandard” on the basis of Visible Particulates in Injections |
| 3. | Infusion Cyanoco (Vitamin B12) 100mL Reg# 041241 | Cyanocobalamin 500 mcg/2mL | International Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna Lahore | Adulterated |
| 4. | Infusion Cyanoco Super 100mL Reg# 041242 | Cyanocobalamin 1000 mcg/2mL | International Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna Lahore | Adulterated |
| 5. | Syrup Desora Reg# 055192 | Desloratadine 0.5mg/mL | S.J. & G. Fazul Ellahie (PVT) Ltd., E-46, S.I.T.E., Karachi | Ethylene Glycol above the permissible limit |
| 6. | Inj. Isanex Reg# 024657 | Sterile Powder of Ceftriaxone Sodium eq. to Ceftriaxone 1g/Vial | Humayun International Pharma (PVT) LTD 20-km, Satiana Road, Faisalabad | “Substandard” with regards to Sterility Test |
| 7. | EmpLiMet XR tablet Reg# 121679 | Empaglifozin, Linagliptin, Metformic HCl | Horizon Healthcare (Pvt.) Ltd., Plot no. 33, sundar Industrial estate, Lahore | Substandard on the basis of Assay |
| Action Initiated | -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/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. |