Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 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: 45963-745-11.
D-0813-2016
Product summary
- Event
- Event 73474
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114,388 Bottles
- Official record key
drug-enforcement:D-0813-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.
Code information: Lot #: 2172#141, Expiry: 3/16; Lot #: 4217K141, Expiry: 3/16; Lot #: 0420A151, Expiry: 7/16; Lot #: 0421A151, Expiry: 7/16; Lot #: 0854B151, Expiry: 10/16; Lot #: 1329C151, Expiry: 10/16; Lot #: 2692F151, Expiry; 2/17; Lot #: 3202G151, Expiry: 3/17; Lot #: 3796J151, Expiry: 3/17; Lot #: 3797J151, Expiry: 4/17.
Distribution pattern: US: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification