Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11

Soucre: MHRA / Gov.uk 8.2.22

Wockhardt 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.

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

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Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11

Published 7 March 2022