Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10
Reported: October 28, 2020 Initiated: October 9, 2020 #D-0044-2021
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10
Reason for Recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Details
- Recalling Firm
- ANI Pharmaceuticals, Inc.
- Units Affected
- 13536 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Baudette, MN
Frequently Asked Questions
What product was recalled? ▼
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10. Recalled by ANI Pharmaceuticals, Inc.. Units affected: 13536 bottles.
Why was this product recalled? ▼
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 28, 2020. Severity: Low. Recall number: D-0044-2021.
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