Rapid Alert
| SPURIOUS/FALSIFIED RHOPHYLAC 300 INJECITION (BATCH NUMBER P100830101) |
| DRAP Alert No | No I/S/11-02-49 |
| Action Date | 2nd November, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | Marketing Authorization Holder (MAH) of the below mentioned product i.e. M/S Hakimsons (Impex) (pvt.) Ltd., Karachi in response to the letter from provincial inspector of drugs, KPK has informed that Batch No. P100830101 of Rhophylac 300 injection available in the market is not associated with their company and does not belong to their authorized product distribution and hence is Spurious as per Section 3(z)(b)(ii) of the Drugs Act, 1976. |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Rhophylac 300 Injection Solution for Injection is pre-filled syringe | P100830101 | Purported to be manufactured by: M/s CSL Behring AG, Switzerland | The authorized supplier has informed that Batch number P100830101 is not associated with their company. |
| Risk Statement | The use of above-mentioned Spurious/Falsified drug product i.e. Rhophylac 300 InjecitonVaccine (Batch # P100830101) may pose serious safety and quality concerns for Public Health as administration of a Spurious/Falsified drug product may fail to provide intended response in the body and could expose recipients 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. |