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 [email protected]