- Medicines and Healthcare products Regulatory Agency
- 6 May 2016
- 6 May 2016
- Alert type:
- Drug alert
- Medical specialty:
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
Aventis Pharma Limited trading as Sanofi
Rifadin 600mg Infusion
|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.
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.
Published: 6 May 2016
Issued: 6 May 2016
Alert type: Drug alert
Medical specialty: Pharmacy