Zoledronic Acid Injection, Solution
FDA Recall NDC 43598-331
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 43598-331). A significant event, classified as Class III, was initiated on Sep 12, 2018 by Dr.reddy's Laboratories Inc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: OOS for unknown impurities."
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
September 2018 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Sep 12, 2018
Oct 03, 2018
10,530 vials
Recall Profile & Regulatory Data
Event ID
81012
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Termination Date
Mar 03, 2020
Product Description
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11
Batch or Lot Expiration Information
Batch# Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
Affected Packages Involved in this Recall
43598-331-11Product
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.
