D-0825-2016 Class II Terminated
FDA drug recall D-0825-2016 was initiated by Impax Laboratories, Inc. on March 14, 2016 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated February 9, 2018). Affected quantity: 67,428 bottles.
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