Class 2 Medicines Recall: UCB Pharma Ltd, Dioctyl 100 mg Capsules, EL (23)A/02

UCB Pharma Ltd is recalling one batch of Dioctyl 100 mg Capsules as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack.

MDR Number: MDR 056-01/23

Company name: UCB Pharma Ltd

Product description: Dioctyl 100 mg Capsules, PL 00039/0737

Details of the affected batch:

Brief description of problem:

UCB Pharma Ltd is recalling the above batch of product as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack. The Marketing Authorisation Holder’s investigation concluded that this was the result of a product mix up during the manufacturing process.

The foreign capsule detected was a blue/green capsule marked with the text ‘IM02’, whereas Dioctyl 100 mg Capsules are opaque yellow and white soft gelatin capsules containing a clear, colourless liquid. The foreign capsule has been identified as loperamide 2mg capsules.

Advice to 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 to Patients:

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. However, if patients discover foreign capsule(s) with a different appearance in a sealed pack of Dioctyl 100mg Capsules, please return the pack to your pharmacy for a replacement. Do not consume the foreign capsule. Any suspected defective medicine should be reported via the MHRA Yellow Card scheme.

Patients who experience adverse reactions or insufficient control of symptoms should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical or supply enquiries, please contact UCB Pharma Ltd on (+44) 01753 777100 or 0800 279 3177 (freephone) or by email at UCBCares.UK@ucb.com.

To access the full recall: Class 2 Medicines Recall: UCB Pharma Ltd, Dioctyl 100 mg Capsules, EL (23)A/02