# FDA recall D-1308-2022

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2022-07-11.

## Product

Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial,  25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1308-2022
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-11
- **Report date:** 2022-08-17
- **Termination date:** 2023-09-14

- **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-1308-2022

## Citation

> AI Analytics. FDA recall D-1308-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1308-2022. Source: US FDA. Licensed CC0.

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