# FDA recall D-0635-2024

> **Hikma Pharmaceuticals USA Inc.** · Class I · drug recall initiated 2024-07-08.

## Product

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ  NDC 0143-9386-01

## Reason for recall

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

## Distribution

OH and PR

## Key facts

- **Recall number:** D-0635-2024
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-07-08
- **Report date:** 2024-08-28

- **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-0635-2024

## Citation

> AI Analytics. FDA recall D-0635-2024. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-0635-2024. Source: US FDA. Licensed CC0.

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