D-841-2013 Class II Terminated
FDA drug recall D-841-2013 was initiated by Sanofi US on March 7, 2013 and is designated Class II. Reason for recall: Subpotent drug: low fill volume in some of the capsules The recall status is terminated (terminated March 17, 2014). Affected quantity: 2,462 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2013
- Initiation Date
- March 7, 2013
- Termination Date
- March 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,462 bottles
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
Reason for Recall
Subpotent drug: low fill volume in some of the capsules
Distribution Pattern
Nationwide
Code Information
Lot # 3097657, Exp 3/15