Drug recall D-1043-2014
Product
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Reason for recall
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Lots and codes
Lots: 524099M, 524100A, 521687A
Recall details
- Recalling firm
- Actavis Inc, Parsippany, NJ
- Quantity
- 139,944 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 15, 2013
- Terminated
- June 16, 2015
Related products
- Bupropion hydrochloride – drug information
- NDC 0591-3331 Bupropion Hydrochloride XL · Bupropion Hydrochloride 150 mg/1 · Actavis Pharma, Inc.