Class 2

Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06

Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06

hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification

MDR number: 054-02/22

Company name: hameln pharma ltd

Product description: Water for Injections BP – 100ml vial, PL 01502/0003R

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

919503

05/2022

25 x 100 ml

12 November 2019

Brief description of the problem:

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.

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.

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

Full Recall: Class 2 Medicines Recall: Hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06