Aventis Pharma Limited trading as Sanofi Rifadin 600mg Infusion

Sanofi is recalling the A5545 batch of Rifadin because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. (EL(16)A/04)

6 May 2016

Action Within 48 Hours

Hospital Pharmacy, Clinic and Wholesale Level Recall

EL Number

(16)A/04

MDR Number

MDR 11-05/16

Company Name

Aventis Pharma Limited trading as Sanofi

Product Description

Rifadin 600mg Infusion

PL 04425/0051

Batch Number/Expiry

Originator Batch No. Expiry Date Pack Size First Distributed
A5545 30 Sep 2019 1 x vial + 10ml solvent 02 Feb 2016

Brief description of the problem

Sanofi is recalling the above batch because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. Pharmacists are asked to quarantine any remaining stock of this batch and return it to the original supplier.

Advice for healthcare professionals and patients

For further information, including stock enquiries, please contact Sanofi Medical Information Department on 0845 3727101 or email UK-Medicalinformation@sanofi.com

If you experience any side-effects, or have any questions or concerns about your health, speak to your doctor, pharmacist, or other healthcare professional. Any suspected side effects can be reported to MHRA through our medicines safety monitoring system, the Yellow Card Scheme or download the Yellow Card App here.

Download document

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Aventis Pharma Limited trading as Sanofi Rifadin 600mg Infusion

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