# FDA recall D-1542-2020

> **Par Pharmaceutical Inc.** · Class II · drug recall initiated 2020-08-10.

## Product

BusPIRone Hydrochloride Tablets, USP 7.5 mg  NDC# 49884-725-01

## Reason for recall

Failed Impurity /Degradation Specifications

## Distribution

Product was distributed to 9 major distributors throughout the United States.

## Key facts

- **Recall number:** D-1542-2020
- **Recalling firm:** Par Pharmaceutical Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-08-10
- **Report date:** 2020-09-02
- **Termination date:** 2021-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chestnut Ridge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1542-2020

## Citation

> AI Analytics. FDA recall D-1542-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1542-2020. Source: US FDA. Licensed CC0.

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