# FDA recall D-0801-2020

> **Hikma Pharmaceuticals USA Inc.** · Class III · drug recall initiated 2020-01-14.

## Product

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

## Reason for recall

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0801-2020
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-01-29
- **Termination date:** 2021-09-08

- **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-0801-2020

## Citation

> AI Analytics. FDA recall D-0801-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0801-2020. Source: US FDA. Licensed CC0.

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