# FDA recall D-0169-2021

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2020-12-07.

## Product

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17

## Reason for recall

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0169-2021
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-07
- **Report date:** 2020-12-23
- **Termination date:** 2023-07-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0169-2021

## Citation

> AI Analytics. FDA recall D-0169-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0169-2021. Source: US FDA. Licensed CC0.

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