Vecuronium Bromide Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 63323-782
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 Vecuronium Bromide (NDC 63323-782). A significant event, classified as Class III, was initiated on Jan 16, 2018 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station."
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
January 2018 Class III Recall: Failed impurities/ degradation specifications
Recall Number
Class III Terminated
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Jan 16, 2018
Feb 07, 2018
35,620 vials
Recall Profile & Regulatory Data
Event ID
78949
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 17, 2019
Product Description
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Batch or Lot Expiration Information
Lot# : ZG603, Exp 11/18
Affected Packages Involved in this Recall
63323-781-21Product
63323-781-10Product
63323-782-23Product
63323-782-20Product
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.
