Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 55150-203
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 Vancomycin Hydrochloride (NDC 55150-203). A significant event, classified as Class II, was initiated on Nov 25, 2019 by Eugia Us Llc. The reported reason for this action was: "Discoloration: Product complaints of discoloration after reconstitution of vials."
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
Discoloration: Product complaints of discoloration after reconstitution of vials.
Nov 25, 2019
Dec 18, 2019
275,060 vials
Recall Profile & Regulatory Data
Event ID
84356
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 04, 2021
Product Description
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Batch or Lot Expiration Information
Lot# : CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Affected Packages Involved in this Recall
55150-203-10Product
55150-204-20Product
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.
