Home / Recalls / Impax Laboratories, Inc. / D-0826-2016

D-0826-2016 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
18,936 bottles

Product Description

Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide

Code Information

Lot #: 112565, Exp 03/17; 113458, Exp 08/17

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-0825-2016 Class II — Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufac (March 14, 2016)