Zoledronic Acid Injection, Solution
FDA Recall NDC 25021-830
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 Zoledronic Acid (NDC 25021-830). A significant event, classified as Class II, was initiated on Mar 04, 2014 by Sagent Pharmaceuticals. The reported reason for this action was: "Lack of Assurance of Sterility; leaking of premix bags"
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
March 2014 Class II Recall: Lack of Assurance of Sterility; leaking of premix bags
Recall Number
Class II Terminated
Lack of Assurance of Sterility; leaking of premix bags
Mar 04, 2014
Oct 08, 2014
10,622 bags
Recall Profile & Regulatory Data
Event ID
67689
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sagent Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 07, 2016
Product Description
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
Batch or Lot Expiration Information
Lot# NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Affected Packages Involved in this Recall
25021-830-82Product
25021-830-87Product
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.
