# FDA recall D-0801-2021

> **Meitheal Pharmaceuticals Inc** · Class III · drug recall initiated 2021-09-03.

## Product

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide within the USA and India

## Key facts

- **Recall number:** D-0801-2021
- **Recalling firm:** Meitheal Pharmaceuticals Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-03
- **Report date:** 2021-09-22
- **Termination date:** 2024-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2021

## Citation

> AI Analytics. FDA recall D-0801-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0801-2021. Source: US FDA. Licensed CC0.

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