Recalls / Class II

Class IID-0814-2016

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.

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Actavis Elizabeth LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106

Distribution

Quantity

257,746 Bottles

Distribution pattern

US: Nationwide

Timeline

Recall initiated

2016-02-16

FDA classified

2016-04-07

Posted by FDA

2016-04-13

Terminated

2017-09-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0814-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.