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 Number: A5545
- Expiry Date: 30 Sep 2019
- Pack Size: 1 x vial + 10ml solvent
- First Distributed: 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.