Drug recall D-0286-2021

Class I Terminated reported Mar 3, 2021

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

Lots and codes

Lot C11507A

Recall details

Recalling firm
Meitheal Pharmaceuticals Inc, Chicago, IL
Quantity
34,860 vials
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
January 27, 2021
Terminated
October 16, 2023

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