Home / Recalls / Impax Laboratories, Inc. / D-0825-2016

D-0825-2016 Class II Terminated

Recalled by Impax Laboratories, Inc. — Middlesex, NJ

Recall Details

Product Type
Drugs
Report Date
April 27, 2016
Initiation Date
March 14, 2016
Termination Date
February 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67,428 bottles

Product Description

Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide

Code Information

Lot # 112579, 112580, Exp 03/17; 111013A, Exp 04/16; 111014, Exp 05/16; 113292, 113332, 113386, 113387, Exp 07/17; 111671,111673, Exp 09/16; 113806, 113807, Exp 10/17; 111874, 111875, 111876, Exp 11/16

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-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)