Recall Enforment Report D-0815-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Actavis Elizabeth LLC, originally initiated on 02-16-2016 for the product Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 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: 45963-749-11. The product was recalled due to failed impurities/degradation specifications: out of specification for impurities.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0815-2016 | 02-16-2016 | 04-13-2016 | Class II | 182,378 Bottles | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 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: 45963-749-11. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
| D-0814-2016 | 02-16-2016 | 04-13-2016 | Class II | 257,746 Bottles | 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. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
| D-0816-2016 | 02-16-2016 | 04-13-2016 | Class II | 38,507 Bottles | 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. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
| D-0813-2016 | 02-16-2016 | 04-13-2016 | Class II | 114,388 Bottles | 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. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
