Recalls / Class III
Class IIID-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
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDC
- 0591-3331
- FDA application
- ANDA077715
- Affected lot / code info
- Lots: 524099M, 524100A, 521687A
Why it was recalled
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Recalling firm
- Firm
- Actavis Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 139,944 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-11-15
- FDA classified
- 2014-01-29
- Posted by FDA
- 2014-02-05
- Terminated
- 2015-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1043-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.