FDA recall D-886-2013

Sanofi-Synthelabo · Class II · drug

Product

Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

Reason for recall

Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.

Distribution

Canada

Key facts

Status
Terminated
Initiation date
2013-02-26
Report date
2013-08-21
Termination date
2014-06-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Laval, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-886-2013