# FDA recall D-0574-2023

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2023-05-11.

## Product

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0574-2023
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-11
- **Report date:** 2023-05-24
- **Termination date:** 2023-12-12

- **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-0574-2023

## Citation

> AI Analytics. FDA recall D-0574-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/D-0574-2023. Source: US FDA. Licensed CC0.

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