FDA recall D-0044-2021

Product

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-10-09

Report date

2020-10-28

Termination date

2022-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baudette, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0044-2021