Recall Enforment Report D-0820-2016
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Impax Laboratories, Inc., originally initiated on 03-17-2016 for the product Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 The product was recalled due to labeling: incorrect or missing lot and/or exp. date. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0820-2016 | 03-17-2016 | 04-20-2016 | Class III | 28,001 HDPE bottles (14,000,500 capsules) | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Terminated |
| D-0821-2016 | 03-17-2016 | 04-20-2016 | Class III | 42,239 HDPE bottles ( 21,119,500 capsules) | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Terminated |
