# FDA recall D-0834-2020

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2020-01-31.

## Product

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.

## Reason for recall

cGMP Deviations

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0834-2020
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-31
- **Report date:** 2020-02-19
- **Termination date:** 2021-10-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0834-2020

## Citation

> AI Analytics. FDA recall D-0834-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0834-2020. Source: US FDA. Licensed CC0.

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