Recall: D-0047-2021

Class III - Minor Violations

Class IIIClassification

2020-10-09Initiated

TerminatedStatus

ANI Pharmaceuticals, Inc.Firm

Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

Reason

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.