Drug 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.
D-0051-2015
Product summary
- Event
- Event 69445
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,499 HDPE bottles
- Official record key
drug-enforcement:D-0051-2015
Official wording
Reason: Labeling: Incorrect or Missing Package Insert
Code information: Lot # 13E019P; Exp 03/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing