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 Number: DMRC- 38515822
Company name:Bio Products Laboratory Limited
Product description: Rabies, Human normal Immunoglobulin 500IU solution for Injection - PL: 08801/0014, SNOMED code: 422303009, GTIN: 15019943000352
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| JRC24208 | April 2027 | 500 IU | October 2024 |
Background information:
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 to 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.
Advice 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 adve
Company contacts for further 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
To access the full recall/alert: Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18