GovWire

DMRC reference number

DMRC-31480052

Company name

Strides Pharma UK Limited

Loperamide Hydrochloride Capsules 2mg, PL 13606/0045

SNOMED Code

18283311000001106

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 batch immediately. Quarantine all remaining stock and return it through your suppliers approved process.

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 theMHRA 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.

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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 2 Medicines Recall: Strides Pharma UK Limited, Loperamide Hydrochloride Capsules 2mg, EL(24)A/38