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 reference number
DMRC-35159465
Marketing Authorisation Holder
Uni Health Distribution Ltd.
Medicine Details
Utrogestan Vaginal 200 mg Capsules
PLPI: 45396/0316
Active ingredient: progesterone
SNOMED code: N/A
GTIN: 5056318902210
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 234376/A | 30/09/2026 | 21 | 12/06/2024 |
| 241347/A | 30/04/2026 | 21 | 25/09/2024 |
| 234376/B | 30/09/2026 | 21 | 25/09/2024 |
| 241347/B | 30/04/2026 | 21 | 24/10/2024 |
| 241347/C | 30/04/2026 | 21 | 26/11/2024 |
| 241347/D | 30/04/2026 | 21 | 27/02/2025 |
Background
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 for 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 for 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.
Additional information:
For further information and all enquiries please contact info@uhdltd.co.uk
Recipients of this Medicines Notification 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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