# FDA recall D-0565-2022

> **ANI Pharmaceuticals, Inc.** · Class II · drug recall initiated 2022-02-15.

## Product

Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

## Reason for recall

cGMP Deviations

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0565-2022
- **Recalling firm:** ANI Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-15
- **Report date:** 2022-02-23
- **Termination date:** 2022-10-25

- **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-0565-2022

## Citation

> AI Analytics. FDA recall D-0565-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0565-2022. Source: US FDA. Licensed CC0.

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