A Class 1 drug alert indicates that the product may cause harm to the patient and action should be taken immediately.
The MHRA is recalling any parallel distributed stock of Lots 3098 and 6Y098 (and lot variants). These lots are genuine Sanofi-Aventis and Bristol Myers Squibb lot numbers for which the original unchanged lots were supplied to France in French livery.
This is the second drug recall in a week, following an alert over counterfeit Zyprexa (olanzapine) - Counterfeit Zyprexa recalled.
The MHRA point out the following issues:
- Parallel distribution companies may have added a prefix or suffix to the lot number, such as 6Y098/1 to differentiate different packing runs. These lot number variants are included in the scope of the recall.
- Parallel distribution companies may occasionally use a completely different lot number on the carton. If the lot number on the carton is not in the format of one of the quoted batch numbers with or without a suffix or prefix, recipients are advised to contact the parallel distributor listed on the carton for clarification. We intend to provide updated data if we receive additional information.
Recipients are requested to quarantine the identified lot numbers (3098 and 6Y098, plus lot variants) and return to sanofi-aventis at Chapeltown Distribution Centre, 51 Cart Road, Chapeltown, Sheffield, South Yorkshire, S35 2PF for examination and suggest you keep full details of any returns.
During normal working hours, please telephone Customer Services (0800 854430), to make arrangements for return, or Medical Information (01483 554919), for medical enquiries. Emergency out of hours number is 01483 505515.
The MHRA alert can be found on their website.