Drug product
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
D-0822-2016
Product summary
- Event
- Event 73715
- Status
- Terminated
- Classification
- Class III
- Quantity
- 228 cartons ( 4,560 capsules)
- Official record key
drug-enforcement:D-0822-2016
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot #144332C; Exp. 04/16 Lot #155224; Exp. 05/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing