Rabies, Human normal Immunoglobulin 500IU solution for Injection
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 2 recall · DMRC- 38515822
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Rabies, Human normal Immunoglobulin 500IU solution for Injection | PL: 08801/0014 | Human Rabies Immunoglobulin | 15019943000352 |
Background: Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency of the Human Rabies immunoglobulin. This action is intended to prevent any potential reduction in clinical effectiveness of the product. No adverse event reports have been received related to this defect. This recall does not impact other batches manufactured that are currently on the market. Advice for Healthcare Professionals: