Class 2

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.

MDR Number: MDR 209-03/22

Company name: USV UK Limited

Product description: Olopatadine USV 1mg/mL eye drops, solution PL 32870/0055

Details of the affected batches:

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

Brief description of 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 to Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Company contacts for further information:

For more information, medical or supply enquiries, please contact info@ennogen.com

To access the full recall: Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17