Rapid Alert
| Spurious/Falsified Hexaxim Vaccine (Batch # X3H421VA) |
| DRAP Alert No | No I/S/11-26-53 |
| Action Date | 12th November, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | M/s Hoechst Pakistan Limited Karachi has informed that the below-mentioned product in vial presentation is not registered nor imported into Pakistan for distribution. The product is registered as Pre-filled Syringe. The availability and use of the below-mentioned Spurious/Falsified presentation i.e. Vial may pose serious health consequences to the patients including therapeutic failure and serious unwanted effects. Following are the details: |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Hexaxim Vaccine Suspension for injection (vial presentation) | X3H421VA | Purported to be manufactured by: M/s Sanofi. | Since M/s Hoechst Pakistan Limited, Karachi has disowned the product in vial presentation therefore, the use of the Spurious/Falsified drug product may pose serious health consequences to the patients. |
| Risk Statement | The use of the above-mentioned Spurious/Falsified drug product may pose serious safety and quality concerns for public health including therapeutic failure, adverse health consequences, or exposure to unknown safety risks. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 on this link. |
| Advice for Consumers | Consumers should not use the above-mentioned product and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |