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  3. Recall Enforcement Event ID: 73679

Recall Enforment Report D-0825-2016

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Impax Laboratories, Inc., originally initiated on 03-14-2016 for the product Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0825-201603-14-201604-27-2016Class II67,428 bottlesDextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10Failed Impurities/Degradation SpecificationsTerminated
D-0826-201603-14-201604-27-2016Class II18,936 bottlesDextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10Failed Impurities/Degradation SpecificationsTerminated