MHRA Class 2 Medicines Recall: Dioctyl 100 mg Capsules (UCB Pharma Ltd)

Drug alert number: EL(23)A/02

Date issued: 18 January 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: Dioctyl 100 mg Capsules, UCB Pharma Ltd – PL 00039/0737

Batch Number Expiry Date Pack Size First Distributed
22983D 30 June 2023 1 x 100 capsules 16 December 2021

Active Pharmaceutical Ingredients: Docusate Sodium

Brief description of the 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, colorless liquid. The foreign capsule has been identified as loperamide 2mg capsules.

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.

Full drug alert can be viewed here.

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.

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