Class 2 Medicines Recall: Largactil 50mg/2ml solution for injection Aventis Pharma Ltd (trading as Sanofi)

Class 2 Medicines Recall: Largactil 50mg/2ml solution for injection Aventis Pharma Ltd (trading as Sanofi)

November 26, 2020

Class 2 MHRA medicines recall – Largactil 50mg/2ml solution for injection Aventis Pharma Ltd (trading as Sanofi) PL 04425/0582
Betahistine dihydrochloride 16mg Tablets (Kent Pharmaceuticals Ltd) PL 30464/0020

Drug alert number: EL (20)A/56

Date issued: 26 November 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Largactil 50mg/2ml solution for injection Aventis Pharma Ltd (trading as Sanofi) PL 30464/0020

Sanofi is recalling the above batches due to out of specification results obtained for the impurity chlorpromazine sulphoxide, which was suspected to be caused by increased oxidation as a result of higher oxygen content in the headspace of the ampoules. As a precautionary measure, the above batches are being recalled.

Product Batch Number Expiry Date Pack Size First Distributed
Largactil 50mg/2ml solution for injection A90142 05/2022 10 x 2ml ampoules 8th April 2020
A90143 05/2022 10 x 2ml ampoules 10th June 2020

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Further information

Full drug alert can be viewed here.

Company contacts for further information

For stock control enquiries please contact GB-CustomerServices@sanofi.com

Telephone: 0800 854 430

For more information or medical information uk-medicalinformation@sanofi.com

Telephone: 0800 035 25 25



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