Rapid Alert
| DRAP Alert No | No I/S/02-25-18 |
| Action Date | 17th February, 2025 |
| Target Audience | 1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public |
| Problem Statement | Drug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below: |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Evosef 250mg capsule (Cephradine 250mg) | HF-001 | Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, Lahore | Spurious. Cephradine not identified | ||
| Mirzpan Suspension 100mg/5ml (Cefixime) | 0008 | M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur. | Spurious, Cefixime not identified | ||
| Mirzolam Tablet 0.5mg (Alprazolam) | 0007 | M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur. | Spurious, Alprazolam not identified | ||
| Bromalax Tablet 3mg (Bromazepam) | B-01 | M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore. | Spurious, Bromazepam not identified | ||
| Malixime Suspension 200mg/5ml (Cefixime) | 78011 | M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi. | Spurious, Cefixime not identified | ||
| Lexopam Tablet 3mg (Bromazepam) | B-01 | M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar. | Spurious, Bromazepam not identified | ||
| Zionex Tablet 0.5mg (Alprazolam) | 0032 | M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi. | Spurious, Alprazolam not identified | ||
| Tramaking-225 Mega tablet 225mg (Tramadol HCl) | TRD2002 | Name of Manufacturer not mentioned. | Spurious | ||
| Alcoxime Suspension 100mg/5ml (Cefixime) | A2011 | M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan. | Spurious, Cefixime not identified |
| Risk Statement: | Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences. |
| Action Initiated | The Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation. |
| Advice for Healthcare Professionals | All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available at this link. |
| Advice for Consumer | Consumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link. |