D-886-2013 Class II Terminated
FDA drug recall D-886-2013 was initiated by Sanofi-Synthelabo on February 26, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 6, 2014). Affected quantity: 998 Bottles.
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