Gentamicin Sulfate Injection, Solution
FDA Recall NDC 0409-1207
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 Sulfate (NDC 0409-1207). A significant event, classified as Class II, was initiated on May 02, 2013 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: visible particles were identified floating in the primary container."
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
Presence of Particulate Matter: visible particles were identified floating in the primary container.
May 02, 2013
Jul 17, 2013
168,300 vals
Recall Profile & Regulatory Data
Event ID
65226
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 28, 2014
Product Description
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Batch or Lot Expiration Information
Lot# Lot 07-067-DK Exp. 07/13
Affected Packages Involved in this Recall
0409-1207-13Product
0409-1207-03Product
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.
