Drug product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
D-0821-2016
Product summary
- Event
- Event 73551
- Status
- Terminated
- Classification
- Class III
- Quantity
- 42,239 HDPE bottles ( 21,119,500 capsules)
- Official record key
drug-enforcement:D-0821-2016
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date
Code information: Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing