Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

DMRC Number: DMRC-35159465

Company name: Uni Health Distribution Ltd.

Product description: Utrogestan Vaginal 200 mg Capsules, PLPI: 45396/0316, GTIN: 5056318902210

Details of the affected batches: 

Brief description of problem:

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

Advice to Healthcare Professionals:

Stop supplying the affected batches 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.

Patients should note that the correct typography ‘mg’ is referenced elsewhere on the carton label, as well as on the blister label and inside the PIL.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For further information and all enquiries please contact info@uhdltd.co.uk

To access the full recall: Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13