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 name
Dioctyl 100 mg Capsules, PL 00039/0737
SNOMED Code
773111000001101
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 322983D | 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.
Advice for 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.
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 [email protected].
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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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