Home / Recalls / Impax Laboratories, Inc. / D-0820-2016

D-0820-2016 Class III Terminated

Recalled by Impax Laboratories, Inc. — Hayward, CA

Recall Details

Product Type
Drugs
Report Date
April 20, 2016
Initiation Date
March 17, 2016
Termination Date
October 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,001 HDPE bottles (14,000,500 capsules)

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

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

Other recalls by Impax Laboratories, Inc.

  • D-0215-2017 Class I — Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters c (August 19, 2016)
  • D-0821-2016 Class III — Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed (March 17, 2016)
  • D-0826-2016 Class II — Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufact (March 14, 2016)
  • D-0825-2016 Class II — Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufac (March 14, 2016)