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Recall Observatory FDA recall evidence

Drug product

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

D-0820-2016

March 17, 2016

Class III

Product summary

Firm
Impax Laboratories, Inc.
Event
Event 73551
Status
Terminated
Classification
Class III
Quantity
28,001 HDPE bottles (14,000,500 capsules)
Official record key
drug-enforcement:D-0820-2016

Official wording

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

Code information: Lot # 10008624, 10008831; Exp. 10/16 Lot # 10009339; Exp. 02/17 Lot # 10009566,10009627; Exp. 04/17 Lot # 10010200, 20001419A, 20001426A; Exp. 10/17 Lot # 20001732A; Exp. 04/18 Lot # 20001790A, 20001791A, 20001792A; Exp. 05/18

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing