Status
Terminated
Drug Enforcement D-841-2013
Subpotent drug: low fill volume in some of the capsules
Classification
Class II
Report Date
August 14, 2013
Termination Date
March 17, 2014
Product Information
- Product description
- 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
- Product quantity
- 2,462 bottles
- Reason for recall
- Subpotent drug: low fill volume in some of the capsules
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Sanofi US
- Address
-
55 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-841-2013
- Event ID
- 65701
- Recall initiation date
- March 7, 2013
- Center classification date
- August 5, 2013
- Code info
- Lot # 3097657, Exp 3/15
- More code info
- —