Recalls / Class III
Class IIID-0048-2021
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Active ingredients
- Amphetamine Dl-aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 43975-277, 43975-278, 43975-279, 43975-280, 43975-282, 43975-281
- FDA application
- ANDA205401
- Affected lot / code info
- Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022
Why it was recalled
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recalling firm
- Firm
- ANI Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 455 Idc Rd Sw, N/A, Baudette, Minnesota 56623-2467
Distribution
- Quantity
- 34968 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-10-09
- FDA classified
- 2020-10-21
- Posted by FDA
- 2020-10-28
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0048-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.