The Recall Desk

FDA (Drugs) recall action 73551

Impax Laboratories, Inc. recalled 2 products on 2016-04-20

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-04-20
Critical
0
Units
—

Why these products were recalled

Labeling: Incorrect or Missing Lot and/or Exp. Date

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • LowFDA (Drugs)··2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 28,001 bottles of Fenofibrate Capsules (Micronized) 134 mg because the bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg because some bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
    Category
    Distribution
    0 states