MHRA 二级药品召回：Bio Products Laboratory 狂犬病人正常免疫球蛋白 500IU 注射液（批号 JRC24208，EL(26)A/18）
Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18
Bio Products Laboratory Limited 召回一批狂犬病人正常免疫球蛋白 500IU 注射液（批号 JRC24208，效期 2027 年 4 月），原因是该批稳定性不合格、效价下降；该批已放行分发 1,414 包，未收到相关不良事件报告，其他在售批次不受影响。
该批因稳定性不合格致效价下降被召回，通报列出批号、效期与已分发包装数，可帮助核对并隔离库存。
Contents
- DMRC reference number
- Marketing Authorisation Holder
- Medicine Details
- Affected Lot Batch Numbers
- Background
- Advice for Healthcare Professionals
- Advice for Healthcare Professionals to Provide to Patients
- Additional information
- Download document
DMRC reference number
DMRC- 38515822
Marketing Authorisation Holder
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
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| JRC24208 | April 2027 | 500 IU | October 2024 |
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.
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 [email protected] or [email protected] or telephone +44 (0)20 89572255, +44 (0)20 89572622 or +44 (0)20 89572200
For stock control enquiries please email [email protected], or telephone +44 (0)20 89572251
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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来源：MHRA 药品召回与缺陷通报 · gov.uk