Rapid Alert
| DRAP Alert No | No I/S/02-25-14 |
| Action Date | 4th 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 | M/s Roche Pakistan Limited, Karachi, has notified DRAP, regarding the sale of counterfeit ‘Laroscorbine Platinum Injection’ in the market across Pakistan. According to the principal, Roche manufactured and marketed Laroscorbine until 2005. In that year, Roche sold the product and brand to Bayer AG. Therefore, any Laroscorbine offered for sale, and which is labeled with the Roche logo or which claims that it was manufactured or marketed by Roche, is not a genuine Roche product. Further informed that as the product does not belong to Roch portfolio, tracing of the lot is not possible: |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Laroscorbine Platinum Injection Reg. No. 0326422 | Purported to be manufactured by M/s Roche Pakistan Limited, Karachi. | Spurious |
| Risk Statement: | The use of Laroscorbine Platinum Injection is believed to brighten the skin and maintain skin elasticity. However, the administration of counterfeit productscould result in treatment failure, worsening of the disease, or life threatening 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. |