Home / Recalls / Meitheal Pharmaceuticals Inc / D-0286-2021

D-0286-2021 Class I Terminated

Recalled by Meitheal Pharmaceuticals Inc — Chicago, IL

Recall Details

Product Type: Drugs
Report Date: March 3, 2021
Initiation Date: January 27, 2021
Termination Date: October 16, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 34,860 vials

Product Description

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 Pattern

Nationwide USA

Code Information

Lot C11507A