Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11
March 8, 2022Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing
From:Medicines and Healthcare products Regulatory Agency
Published 7 March 2022
Contents
- MDR Number
- Company name
- Product description
- Brief description of the problem
- Advice for healthcare professionals
- Further Information
- Download document
MDR Number
MDR 046-03/22
Company name
Wockhardt UK Ltd
Product description
Diazepam RecTubes 2.5mg Rectal Solution PL 29831/0067
Batch Number | Expiry Date | Pack Size | First Distributed |
I55061 | January 2023 | 5x 1.25ml | 27 April 2020 |
Active Pharmaceutical Ingredient: Diazepam
Brief description of the problem
Wockhardt UK Ltd are recalling the above batch due to an out of specification result for assay during routine stability testing.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information, medical or supply enquiries, please contact: drug.safety@wockhardt.co.uk
For stock control queries, please contact: customer.services@wockhardt.co.uk
Recipients of this Medicines Notification 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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Published 7 March 2022