PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 27, 2016 Initiated: March 14, 2016 #D-0825-2016

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

Details

Recalling Firm
Impax Laboratories, Inc.
Units Affected
67,428 bottles
Distribution
Nationwide
Location
Middlesex, NJ

Frequently Asked Questions

What product was recalled?
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10. Recalled by Impax Laboratories, Inc.. Units affected: 67,428 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on April 27, 2016. Severity: Moderate. Recall number: D-0825-2016.