class 3

Class 3 Medicines Recall: Bimatoprost Aspire 0.3mg/ml eye drops, solution in single-dose container, Aspire Pharma Limited, EL (21)A/26

Aspire Pharma Limited is recalling the below batches of Bimatoprost Aspire 0.3mg/ml eye drops, solution in single dose container 0.4ml x 30 as a precautionary measure.

MDR Number MDR 052-08/21

Company name Aspire Pharma Limited

Product description Bimatoprost Aspire 0.3mg/ml eye drops, solution in single dose container 0.4ml x 30 PL 35533/0128

Details of the affected batches:

Batch Number

Expiry Date

Pack Size

First Distributed

1590121

31/01/2023

30

04/03/21

1590221

31/01/2023

30

07/05/21

1590321

31/01/2023

30

28/06/21

1593920

31/01/2023

30

05/08/21

1594020

31/01/2023

30

21/09/21

Brief description of problem

Aspire Pharma Limited is recalling the above batches of Bimatoprost Aspire 0.3mg/ml eye drops, solution in single dose container 0.4ml x 30 as a precautionary measure due to the identification of some variability in the thickness of plastic of the single dose containers resulting in some patients finding the containers difficult to squeeze due to increased hardness of individual containers.

 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

Customer Services for stock control enquiries:

Email: customerservices@aspirepharma.co.uk  Tel. 01730 231148

 Medical Information enquiries:

Email: medinfo@aspirepharma.co.uk  Tel. 01730 231148

To access the full recall: Class 3 Medicines Recall: Bimatoprost Aspire 0.3mg/ml eye drops, solution in single-dose container, Aspire Pharma Limited, EL (21)A/26