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
Water for Injections BP – 100ml vial, PL 01502/0003R
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 919503 | 05/2022 | 25 x 100 ml | 12 November 2019 |
Active Pharmaceutical Ingredient: Water for Injections
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
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.
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