Recalls / Class III
Class IIID-0052-2015
Product
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
- Affected lot / code info
- Lot #: a) 13E020P; Exp. 03/17 Lot #: b) 13E029P, 13E028P, 13K032P; 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
- 23,057 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-0052-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.