Cisatracurium Besylate Injection, Solution
FDA Recall NDC 71288-714
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cisatracurium Besylate (NDC 71288-714). A significant event, classified as Class I, was initiated on Jan 27, 2021 by Meitheal Pharmaceuticals Inc.. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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
Jan 27, 2021
Mar 03, 2021
34,860 vials
Recall Profile & Regulatory Data
Event ID
87224
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Meitheal Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Oct 16, 2023
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.
Batch or Lot Expiration Information
Lot# Lot C11507A
Affected Packages Involved in this Recall
71288-712-05Product
71288-712-06Product
71288-714-10Product
71288-714-11Product
71288-713-20Product
71288-713-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
