Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A/24
hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
MDR number
054-02/22
Company name
hameln pharma ltd
Product name
Water for Injections BP – 100ml vial PL 01502 / 0003R
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 920503 | 05/2022 | 25 x 100 ml | 29/11/2019 |
| 920506 | 05/2022 | 25 x 100 ml | 17/12/2019 |
| 920508 | 05/2022 | 25 x 100 ml | 07/01/2020 |
| 930503 | 07/2022 | 25 x 100 ml | 21/01/2020 |
| 930504 | 07/2022 | 25 x 100 ml | 07/02/2020 |
| 930505 | 07/2022 | 25 x 100 ml | 25/02/2020 |
| 931501 | 07/2022 | 25 x 100 ml | 12/03/2020 |
| 940501 | 10/2022 | 25 x 100 ml | 25/03/2020 |
| 940502 | 10/2022 | 25 x 100 ml | 21/04/2020 |
| 951504 | 12/2022 | 25 x 100 ml | 11/05/2020 |
| 952501 | 12/2022 | 25 x 100 ml | 04/06/2020 |
| 019501 | 05/2023 | 25 x 100 ml | 03/07/2020 |
| 019502 | 05/2023 | 25 x 100 ml | 17/07/2020 |
| 019503 | 05/2023 | 25 x 100 ml | 05/08/2020 |
| 019504 | 05/2023 | 25 x 100 ml | 26/08/2020 |
| 019505 | 05/2023 | 25 x 100 ml | 21/10/2020 |
| 019506 | 05/2023 | 25 x 100 ml | 06/11/2020 |
Active Pharmaceutical Ingredient: Water for Injections
Brief description of the problem
Following further investigations, hameln pharma ltd are recalling the above batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
This recall is conducted as a precautionary measure, as remaining vials may no longer be in line with the licensed product specification with respect to the parameters pH and conductivity.
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock of these batches 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 these batches or to arrange replacement batches.
Although the Marketing Authorisation Holder have not received any reports of adverse reactions related to the issue above, any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Advice to patients
No further action is required by patients as this is a Pharmacy and Wholesaler level recall.
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
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.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A/24