D-886-2013 Class II Terminated

Recalled by Sanofi-Synthelabo — Laval

Recall Details

Product Type
Drugs
Report Date
August 21, 2013
Initiation Date
February 26, 2013
Termination Date
June 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
998 Bottles

Product Description

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 Pattern

Canada

Code Information

Lot # 3099036, Exp 03/2014