Rocuronium Bromide Injection, Solution
FDA Recall NDC 55150-225
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 Rocuronium Bromide (NDC 55150-225). A significant event, classified as Class II, was initiated on Feb 07, 2024 by Eugia Us Llc. The reported reason for this action was: "cGMP Deviations: Products were stored outside the drug label specifications."
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 II Terminated
cGMP Deviations: Products were stored outside the drug label specifications.
Feb 07, 2024
Mar 20, 2024
70 vials
Recall Profile & Regulatory Data
Event ID
93935
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to three direct accounts in NM, AZ and UT.
Termination Date
Aug 14, 2024
Product Description
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Batch or Lot Expiration Information
Lot# 1064081
Affected Packages Involved in this Recall
55150-225-05Product
55150-226-10Product
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.
