Rapid Alert
| DRAP Alert No | No I/S/11-24-42 |
| Action Date | 07th November, 2024 |
| Target Audience | · National Regulatory Field Force. · Distribution, Pharmacies and Medical Stores · Healthcare Professionals – Physician, Pharmacist, Nurses · Maternal and Child Health Centres |
| Problem Statement | M/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number. |
| Product name | Batch/Lot No. | Manufacturer Name (as per label) | Mfg. date | Exp. date |
| Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin | P100547971 P100644011 Barcode Batch: P100585096 | M/s CSL Behring AG, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland. | 10-2023 | 09-2026 |
| Threat to Public Health | The Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. 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 Consumer | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these 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.