Status
Terminated
Drug Enforcement D-886-2013
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.
Classification
Class II
Report Date
August 21, 2013
Termination Date
June 6, 2014
Product Information
- 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
- Product quantity
- 998 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Canada
Location & Firm
- Recalling firm
- Sanofi-Synthelabo
- Address
-
2150 Boul Saint Elzear O
Canada - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-886-2013
- Event ID
- 65954
- Recall initiation date
- February 26, 2013
- Center classification date
- August 13, 2013
- Code info
- Lot # 3099036, Exp 03/2014
- More code info
- —