Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 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: 45963-743-11.
D-0816-2016
Product summary
- Event
- Event 73474
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,507 Bottles
- Official record key
drug-enforcement:D-0816-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.
Code information: Lot #: 5245M141, Expiry: 6/16; Lot #: 0953C151, Expiry date: 8/16Lot #: 1728D151, Expiry: 9/16; Lot #: 3205G152, Expiry: 3/17.
Distribution pattern: US: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification