Rapid Alert
| SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA) |
| DRAP Alert No | No I/S/03-26-11 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab has declared the following sample of product as Spurious under Section 3(zb)(ii), Misbranded under Section 3(s)(vi), and Substandard under the Drugs Act, 1976. |
| S# | Product Name | Batch No. | Manufacturer (as per label) | Test Result |
| 1 | Injection Venofer 5 mL (Iron Sucrose 100 mg/5 mL) | 4721026AA | Purported to be manufactured by Takeda Austria GmbH, Austria Imported by: M/s Searle Pakistan Limited | Declared Spurious, Misbranded & Substandard (Assay failure of Iron & Sucrose) |
The product is purported to be manufactured by Takeda Austria GmbH, Austria and imported by M/s Searle Pakistan Limited. However, the authorized importer has officially disowned the recovered sample and confirmed, after physical comparison with their retention sample of the same batch, that the provided sample is counterfeit.
Laboratory analysis revealed failure of assay for Iron and Sucrose contents, while sterility test complied. The product also does not contain finished drug product specifications.
| Risk Statement | The product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| 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 these products 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. |