MHRA Class 2 Medicines Recall: Water for Injections BP 100ml vial (hameln) – Updated

Update 25/05/22: Additional batches added to recall: 

Batch Number Expiry Date Pack Size First Distributed
920503 05/2022 25 x 100ml 29/11/2019
920506 05/2022 25 x 100ml 17/12/2019
920508 05/2022 25 x 100ml 07/01/2020
930503 07/2022 25 x 100ml 21/01/2020
930504 07/2022 25 x 100ml 07/02/2020
930505 07/2022 25 x 100ml 25/02/2020
931501 07/2022 25 x 100ml 12/03/2020
940501 10/2022 25 x 100ml 25/03/2020
940502 10/2022 25 x 100ml 21/04/2020
951504 12/2022 25 x 100ml 11/05/2020
952501 12/2022 25 x 100ml 04/06/2020
0195501 05/2022 25 x 100ml 03/07/2020
019502 05/2022 25 x 100ml 17/07/2020
019503 05/2022 25 x 100ml 05/08/2020
019504 05/2022 25 x 100ml 26/08/2020
019505 05/2022 25 x 100ml 21/10/2020
019506 05/2022 25 x 100ml 06/11/2020

 


Class 2 Medicines recall: Water for Injections BP 100ml vial (hameln)

Drug alert number: EL (22) A/06

Date issued: 15th February 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Water for Injections BP 100ml vial (hameln) PL 01502/0003R

Following the identification, during routine ongoing stability studies, of out of specification (OOS) results for the parameters pH and Conductivity, hameln pharma ltd is recalling batch 919503 of the above mentioned product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification. Please note, this recall is for Water for Injections BP – 100ml vial Batch Number 919503 only and no other batches are affected. This batch has an expiry date of 05/2022.

Batch Number Expiry Date Pack Size
919503 05.2022 100ml

Advice for healthcare professionals

Please quarantine any remaining stock of this batch and contact hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk to arrange credit for any unused vials from this batch.

Replacement batches of Water for Injections BP – 100ml vials (product code: W100) are available from hameln pharma ltd and supplies will be maintained.

Full drug alert can be viewed here.

Company contacts for further information

For more information or supply queries, please contact or email hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk

For medical information queries, please contact or email hameln pharma ltd Medicines Information on +44 (0)1452 621 661 or drug.safety@hameln-pharma.co.uk

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