Class 2 Medicines Recall: Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited, EL (25)A/23
Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the packs, identified when the packs have been opened by healthcare professionals.
DMRC reference number
DMRC-35559868
Marketing Authorisation Holder
Aspen Pharma Trading Limited
Medicine Details
Mercaptopurine 50mg tablets
PL: 39699/0047
Active ingredient: mercaptopurine
SNOMED code: 22519811000001102
GTIN: 05060598250817
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P0010384 | 31/12/2028 | 25 | 08/01/2025 |
Background
Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the packs, identified when the packs have been opened by healthcare professionals. The contamination has been identified as Penicillium Kongii.
Advice for Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice for Patients:
Patients or carers should check to see if they have received tablets from the listed batch of Mercaptopurine 50 mg tablets (Batch P0010384). The batch number can be found on the label of the medicine bottle.
The tablets should be a ‘pale yellow colour and are marked with ‘PT / 50’, as per the Patient Information Leaflet (PIL). If you have tablets that are discoloured in any way, from the affected batch please contact your relevant healthcare professional responsible for your treatment, e.g. specialist or prescriber.
Patients should not stop taking their medication without discussing this with their specialist or prescriber as there may be a need for additional monitoring.
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 Aspenmedinfo@professionalinformation.co.uk or telephone 01748 828391
For stock control enquiries please email uk.stockenquiries@aspenpharma.eu
Recipients of this Medicines Notification 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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