PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 27, 2016 Initiated: March 14, 2016 #D-0826-2016

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

Details

Recalling Firm
Impax Laboratories, Inc.
Units Affected
18,936 bottles
Distribution
Nationwide
Location
Middlesex, NJ

Frequently Asked Questions

What product was recalled?
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10. Recalled by Impax Laboratories, Inc.. Units affected: 18,936 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-0826-2016.