Drug product
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
D-841-2013
Product summary
- Firm
- Sanofi US
- Event
- Event 65701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,462 bottles
- Official record key
drug-enforcement:D-841-2013
Official wording
Reason: Subpotent drug: low fill volume in some of the capsules
Code information: Lot # 3097657, Exp 3/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent