FDA Drug recall D-0045-2021
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single…
- FDA Drug
- Class III
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class III recall of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single… by Ani Pharmaceuticals, citing labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0045-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-09 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ani Pharmaceuticals |
| Distribution | US |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10
Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Identifiers
| ndc | 43975-277-10 |
|---|---|
| ndc | 43975-278-10 |
| ndc | 43975-279-10 |
| ndc | 43975-280-10 |
| ndc | 43975-282-10 |
| ndc | 43975-281-10 |
| code_info | Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0045-2021%22
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