Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56
Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide
PL Number(s)
PL 04425/0582
MDR Number
MDR 140-11/20
Company Name
Aventis Pharma Limited (t/a Sanofi)
Product description
Largactil 50mg/2ml Solution for Injection
- Batch Number: A90142
- Expiry Date: 05/2022
- Pack Size: 10x2ml ampoules
- First Distributed: 08 April 2020
- Batch Number: A90143
- Expiry Date: 05/2022
- Pack Size: 10x2ml ampoules
- First Distributed: 10 June 2020
Active Pharmaceutical Ingredient: chlorpromazine hydrochloride
Brief description of the problem
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.
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
For stock control enquiries please contact GB-CustomerServices@sanofi.com
Phone number: 0800 854 430
For more information or medical information at uk-medicalinformation@sanofi.com
Phone number: 0800 035 25 25
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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