Gentamicin Injection, Solution
FDA Recall NDC 63323-010
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 Gentamicin (NDC 63323-010). A significant event, classified as Class II, was initiated on Nov 12, 2014 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Defective Container: Vials may be missing stoppers."
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
Defective Container: Vials may be missing stoppers.
Nov 12, 2014
Dec 17, 2014
92,125 vials
Recall Profile & Regulatory Data
Event ID
69810
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 08, 2016
Product Description
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Batch or Lot Expiration Information
Lot# Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Affected Packages Involved in this Recall
63323-010-01Product
63323-010-02Product
63323-010-03Product
63323-010-20Product
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.
