FDA Drug recall D-0814-2016
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx…
- FDA Drug
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx… by Actavis Elizabeth, citing failed Impurities/Degradation Specifications: Out of specification for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0814-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Elizabeth |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Identifiers
| code_info | Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Actavis Elizabeth
- NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Eliza…
FDA Drug · Class III · 2016-11-30 · Actavis Elizabeth - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx O…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth - Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, N…
FDA Drug · Class II · 2015-03-11 · Actavis Elizabeth
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0814-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.