Drug 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
D-0052-2015
Product summary
- Event
- Event 69445
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23,057 HDPE bottles
- Official record key
drug-enforcement:D-0052-2015
Official wording
Reason: Labeling: Incorrect or Missing Package Insert
Code information: Lot #: a) 13E020P; Exp. 03/17 Lot #: b) 13E029P, 13E028P, 13K032P; Exp. 03/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing