D-0045-2021 Class III Terminated
FDA drug recall D-0045-2021 was initiated by ANI Pharmaceuticals, Inc. on October 9, 2020 and is designated Class III. Reason for recall: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. The recall status is terminated (terminated January 19, 2022). Affected quantity: 13248 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 28, 2020
- Initiation Date
- October 9, 2020
- Termination Date
- January 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13248 bottles
Product Description
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 for Recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022