Recall Alert
| DRAP Alert No | No I/S/04-25-37 |
| Action Date | 22nd April, 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 | Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Omsana-AM Tablet Reg. No. 058557 | Each film coated tablet contains: Amlodipine (as besylate).…5mg Olmesartan Medoxomil….20mg | 155367 | M/s Hilton Pharma (Pvt) Ltd, Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi. | ‘Substandard’ on the basis of Test for Impurities (Organic impurities). |
| BYTEC Tablet Reg. No. 036183 | Each film coated tablet contains: Cetirizine dihydrochloride.…10mg | E605 | M/s. Batala Pharmaceuticals, 23/B, Small Industrial Estate # 2, Gujranwala. | ‘Adulterated’ as defined under clause (iv) of sub-section (a) of section 3 of Drugs Act, 1976. |
| Myteka Sachet Reg. No. 039695 | Each sachet contains: Montelukast sodium eq. to Montelukast…..4mg | 155384 | M/s Hilton Pharma (Pvt) Ltd, Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi. | ‘Substandard’ on the basis of Assay Test & Test for Impurities (Organic impurities). |
| Isanex 1g Injection Reg. No. 024657 | Each vial contains: Ceftriaxone sodium eq. to ceftriaxone…1g | IA-703 | M/s Humayun International Pharma (Pvt) Ltd., 20-Km, Satiana Road, Faisalabad. | ‘Substandard’ on the basis of Sterility test & Bacterial Endotoxin Test |
| Medi-Lox Tablet Reg. No. 056133 | Each film coated tablet contains: Ciprofloxacin as HCl….250mg | 425 | M/s Medicon Pharmaceutical Industries (Pvt) Ltd., B-1/11, Industrial Estate, Hyatabad, Peshawar. | ‘Substandard’ on the basis ofDissolution Test. |
| Risk Statement: | The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population. |
| 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. |