Rabies treatment recalled following stability failure

Bio Products Laboratory Limited is recalling one batch of the post-exposure rabies treatment, human rabies immunoglobulin, following a stability failure and a reduction in potency.

This class 2 recall specifically relates to human normal immunoglobulin 500IU solution for injection and this action is intended to prevent any potential reduction in clinical effectiveness of the product.

The recall is a precautionary measure, and, to date, no adverse event reports have been received related to this defect. Bio Products Laboratory Limited also state that this recall does not impact other batches that are currently on the market.

Healthcare professionals are advised to stop supplying the affected batch immediately, and to quarantine all stock and return it to their supplier using the supplier’s approved process.

Bio Products Laboratory Limited can confirm that 1,414 packs of this batch have been released and distributed.

Human rabies immunoglobulin is a medication that is made from human blood that has high levels of antibodies against the rabies virus. Multiple doses are given prophylactically in cases of high-risk exposure to the virus.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.