Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17
USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
Company name
USV UK Limited
Product name
Olopatadine USV 1mg/mL eye drops, solution PL 32870/0055
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 35000201 | 07/2023 | 5ML | 14 July 2021 |
| 35000202 | 07/2023 | 5ML | 27 July 2021 |
| 35000203 | 07/2023 | 5ML | 5 August 2021 |
| 35000204 | 07/2023 | 5ML | 29 November 2021 |
| 35000206 | 07/2023 | 5ML | 23 July 2021 |
Active Pharmaceutical Ingredient: Olopatadine hydrochloride
MDR number
MDR 209-03/22
Brief description of the problem
USV UK Limited are recalling the affected batches as a precautionary measure due to out of specification results for impurities during routine stability testing. The company’s investigation is on-going.
Advice for healthcare professionals
Stop supplying the above 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.
Although the Marketing Authorisation Holder have not received any reports of adverse reactions related to the issue above, patients who experience adverse reactions should seek immediate 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 info@ennogen.com
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.
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