MHRA Class 2 Medicines Recall: Loperamide Hydrochloride Capsules 2mg (Strides Pharma UK Limited)

Drug alert number: EL (24)A/36

Date issued: 15 July 2024

Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting: Loperamide Hydrochloride Capsules 2mg (Strides Pharma UK Limited) PL 13606/0045

SNOMED Code: 18283311000001106

Batch No Expiry Date Pack Size First Distributed
EG23LPA006 06/2027 3 x 10 19 March 2024

Active Pharmaceutical Ingredient: Loperamide Hydrochloride

Brief description of the problem

Strides Pharma UK Ltd is recalling the above batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.

Only the batch specified in the table, a prescribed loperamide product, is known to be affected.

Advice for healthcare professionals

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

Full drug alert can be viewed here.

Advice for patients

No action is required by patients as this is a Pharmacy and Wholesaler level recall. There have been no reports of patients being harmed or becoming ill from taking this medicine. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

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.

Further Information

For medical information enquiries please email dl-drugsafety@strides.com and DL-GPV-Group@arcolab.com or telephone 01923 255580.

For stock control enquiries please email customerservicesuk@stridespharma.co.uk or telephone 01923 255580.