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Recall Observatory FDA recall evidence

Drug 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

D-0825-2016

March 14, 2016

Class II

Product summary

Firm
Impax Laboratories, Inc.
Event
Event 73679
Status
Terminated
Classification
Class II
Quantity
67,428 bottles
Official record key
drug-enforcement:D-0825-2016

Official wording

Reason: Failed Impurities/Degradation Specifications

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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications