Medicines recallMHRA
Rabies, Human normal Immunoglobulin 500IU solution for Injection recalled over a strength or dose problem
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Rabies, Human normal Immunoglobulin 500IU solution for Injection 500 IU
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- JRC24208
- ExpiryOn the carton, blister or label.
- April 2027
- First distributedOn the product, its label or its packaging.
- October 2024
What to do now
Rabies, Human normal Immunoglobulin 500IU solution for Injection has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/18). Quoted as issued.
Summary
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.
The risk
DMRC reference number DMRC- 38515822 Marketing Authorisation Holder
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.
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.
Advice for 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.
Open the MHRA notice
Questions
Why has Rabies, Human normal Immunoglobulin 500IU solution for Injection been recalled?
Rabies, Human normal Immunoglobulin 500IU solution for Injection has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.