# FDA recall D-0044-2021

> **ANI Pharmaceuticals, Inc.** · Class III · drug recall initiated 2020-10-09.

## 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

- **Recall number:** D-0044-2021
- **Recalling firm:** ANI Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0044-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0044-2021. Source: US FDA. Licensed CC0.

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