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Recall Observatory FDA recall evidence

Drug product

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.

D-0814-2016

February 16, 2016

Class II

Product summary

Firm
Actavis Elizabeth LLC
Event
Event 73474
Status
Terminated
Classification
Class II
Quantity
257,746 Bottles
Official record key
drug-enforcement:D-0814-2016

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.

Code information: Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7/16; Lot #: 0378A151, Expiry: 7/16; Lot #: 0379A151, Expiry: 7/16; Lot #: 0697B151, Expiry: 8/16; Lot #: 2427F151, Expiry: 11/16; Lot #: 1947E151, Expiry: 11/16; Lot #: 1330C151, Expiry: 11/16; Lot #: 1331C151, Expiry: 11/16; Lot #: 1946E151, Expiry: 11/16; Lot #: 3652H151, Expiry: 2/17; Lot #: 3653H151, Expiry: 3/17, Lot #: 3654H151, Expiry: 3/17; Lot #: 4251K151, Expiry: 3/17; Lot #: 4250K151, Expiry: 4/17; Lot #: 4252K151, Expiry: 4/17; Lot #: 4249K151, Expiry: 4/17; Lot #: 5101M151, Expiry: 5/17.

Distribution pattern: US: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification