Drug product
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
D-0823-2016
Product summary
- Event
- Event 73715
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,034 cartons (151,020 capsules)
- Official record key
drug-enforcement:D-0823-2016
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot #142548; Exp. 05/16 Lot #145036; Exp. 10/16 Lot #151170; Exp. 03/17 Lot #152978; Exp. 09/17 Lot #155080; Exp. 01/18.
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing