Drug recall
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward…
FDA recall event 73551 · Class III · Impax Laboratories, Inc.
Key facts
| Event ID | 73551 |
|---|---|
| Recall numbers | D-0820-2016, D-0821-2016 |
| Recalling firm | Impax Laboratories, Inc. |
| Product type | Drugs |
| Products | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02, Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp. Date |
| Initiation date | Mar 17, 2016 |
| Report date | Apr 20, 2016 |
| Termination date | Oct 27, 2016 |
| City | Hayward |
| State | CA |
| Country | United States |
| FEI number | 3004182921 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: