Recalls / Class III
Class IIID-0051-2015
Product
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
- Affected lot / code info
- Lot # 13E019P; Exp 03/17
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807
Distribution
- Quantity
- 20,499 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-05
- FDA classified
- 2014-10-28
- Posted by FDA
- 2014-11-05
- Terminated
- 2017-07-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0051-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.