# FDA recall D-0091-2023

> **AVKARE LLC** · Class II · drug recall initiated 2022-12-22.

## Product

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

## Reason for recall

Failed impurities/degradation specifications: Out of specification for unknown impurities.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0091-2023
- **Recalling firm:** AVKARE LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-12-22
- **Report date:** 2023-01-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0091-2023

## Citation

> AI Analytics. FDA recall D-0091-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0091-2023. Source: US FDA. Licensed CC0.

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