D-175-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2013
- Initiation Date
- January 4, 2013
- Termination Date
- January 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,856 bottles
Product Description
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Reason for Recall
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Distribution Pattern
Nationwide
Code Information
Lot CB1D05A,