# FDA recall D-1185-2018

> **Par Pharmaceutical, Inc.** · Class III · drug recall initiated 2018-09-06.

## Product

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

## Reason for recall

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

## Distribution

United States nationwide

## Key facts

- **Recall number:** D-1185-2018
- **Recalling firm:** Par Pharmaceutical, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-06
- **Report date:** 2018-09-19
- **Termination date:** 2019-12-06

- **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-1185-2018

## Citation

> AI Analytics. FDA recall D-1185-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1185-2018. Source: US FDA. Licensed CC0.

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