Manufacturer UCB Pharma Ltd is recalling one batch of Dioctyl 100mg capsules “as a precautionary measure”, the Medicines and Healthcare products Regulatory Agency (MHRA) said in an alert issued this week (January 18).
This is due to a “foreign capsule being found in a sealed pack”, it said.
According to an investigation by the Marketing Authorisation Holder, the capsule was mistakenly placed in the pack as “the result of a product mix-up during the manufacturing process”, the alert added.
The foreign capsule – which has been identified as loperamide 2mg capsules - was blue/green and marked with the text “IM02”, the MHRA said.
Dioctyl 100mg capsules are opaque yellow and white soft gelatine capsules and contain a clear colourless liquid, it added.
Stop supply “immediately”
Pharmacists must “stop supplying” the affected batch - 322983D – “immediately” and “quarantine all remaining stock” and return it to their supplier, the MHRA said.
Patients who “discover foreign capsule(s) with a different appearance in a sealed pack” of the capsules should not consume the foreign capsule but should return the pack to their pharmacy for a replacement, it added.
“Any suspected defective medicine should be reported via the MHRA Yellow Card scheme,” as well as any suspected adverse reactions, it said.
Batch details
Product name: Dioctyl 100mg Capsules, PL 00039/0737
SNOMED code: 773111000001101
Batch number: 322983D
Expiry date: June 30 2023
Pack size: 1 x 100 capsules
First distributed: December 16 2021
Active pharmaceutical ingredients: Docusate Sodium.
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