# FDA recall D-0286-2021

> **Meitheal Pharmaceuticals Inc** · Class I · drug recall initiated 2021-01-27.

## Product

Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06),  Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.

## Reason for recall

Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0286-2021
- **Recalling firm:** Meitheal Pharmaceuticals Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-27
- **Report date:** 2021-03-03
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2021

## Citation

> AI Analytics. FDA recall D-0286-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0286-2021. Source: US FDA. Licensed CC0.

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