# FDA recall D-1071-2020

> **Par Pharmaceutical Inc.** · Class II · drug recall initiated 2020-03-30.

## Product

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India   NDC# 49884-0065-01

## Reason for recall

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

## Distribution

Product was distributed within the United States.

## Key facts

- **Recall number:** D-1071-2020
- **Recalling firm:** Par Pharmaceutical Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-30
- **Report date:** 2020-04-08
- **Termination date:** 2021-11-02

- **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-1071-2020

## Citation

> AI Analytics. FDA recall D-1071-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1071-2020. Source: US FDA. Licensed CC0.

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