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
D-886-2013
Product summary
- Event
- Event 65954
- Status
- Terminated
- Classification
- Class II
- Quantity
- 998 Bottles
- Official record key
drug-enforcement:D-886-2013
Official wording
Reason: 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.
Code information: Lot # 3099036, Exp 03/2014
Distribution pattern: Canada
Derived failure modes
-
Potency or specification failure
Subpotent