January 2021 FDA Recall Cisatracurium Besylate by Meitheal Pharmaceuticals Inc
D-0286-2021 - Labeling

This Class I drug recall was voluntarily initiated by Meitheal Pharmaceuticals Inc on January 27, 2021 for the product Cisatracurium Besylate. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0286-2021

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
Initiated
01-27-2021
Reported
03-03-2021
Quantity
34,860 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87224
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Meitheal Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot C11507A

Affected Packages Involved in this Recall

71288-712-05 Cisatracurium Besylate
71288-712-06 Cisatracurium Besylate
71288-714-10 Cisatracurium Besylate
71288-714-11 Cisatracurium Besylate
71288-713-20 Cisatracurium Besylate
71288-713-21 Cisatracurium Besylate