# FDA recall D-0853-2020

> **AuroMedics Pharma LLC** · Class III · drug recall initiated 2020-02-07.

## Product

Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.

## Reason for recall

Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

## Distribution

Ohio, Louisiana, Mississippi

## Key facts

- **Recall number:** D-0853-2020
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-07
- **Report date:** 2020-02-26
- **Termination date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2020

## Citation

> AI Analytics. FDA recall D-0853-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0853-2020. Source: US FDA. Licensed CC0.

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