FDAFDA · Food and drugs·Recall number D-0048-2021
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
Published October 28, 2020 · Recall initiated: October 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0343975282102
- Lot
- Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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