Home / Recalls / Impax Laboratories, Inc. / D-0821-2016

D-0821-2016 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
42,239 HDPE bottles ( 21,119,500 capsules)

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18

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-0820-2016 Class III — Fenofibrate Capsules (Micronized) 134 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)