MHRA Class 2 Medicines Recall: Rabies, Human normal Immunoglobulin 500IU solution for Injection (Bio Products Laboratory Limited)

MHRA Class 2 Medicines Recall: Rabies, Human normal Immunoglobulin 500IU solution for Injection (Bio Products Laboratory Limited)

Drug alert number: EL(26)A/18

Date issued: 30 March 2026

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.

DMRC reference number: DMRC-38515822

Company name: Bio Products Laboratory Limited

Medicine Details

Rabies, Human normal Immunoglobulin 500IU solution for Injection (PL: 08801/0014)

Active ingredient: Human Rabies Immunoglobulin

SNOMED code: 422303009

GTIN: 15019943000352

Affected Lot Batch Numbers:

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

Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Bio Products Laboratory Limited can confirm that 1,414 packs of this batch have been released and distributed. No related adverse event reports have been received related to this defect.

View the full alert here.

Advice for Healthcare Professionals to Provide to Patients:

No action is required by patients as this product is administered by healthcare professionals only, who will ensure the affected stock is removed from use.

The recall is a precautionary measure to mitigate the risk of a loss of efficacy of the product once administered. No adverse event reports have been received related to this issue. Patients who may have received treatment from these batches will not need to take any action.

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.

Additional information:

For all medical information enquiries and information on this product, please email medinfo@bpl.co.uk  or medinfo@kedrion.com or telephone +44 (0)20 89572255, +44 (0)20 89572622 or +44 (0)20 89572200

For stock control enquiries please email bplorders@kedrion.com, or telephone +44 (0)20 89572251.

The post MHRA Class 2 Medicines Recall: Rabies, Human normal Immunoglobulin 500IU solution for Injection (Bio Products Laboratory Limited) appeared first on Community Pharmacy England.