Zoledronic Acid Injection, Solution
FDA Recall NDC 55111-688
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Zoledronic Acid (NDC 55111-688). A significant event, classified as Class II, was initiated on May 23, 2024 by Dr.reddy's Laboratories Ltd. The reported reason for this action was: "Lack of Assurance of Sterility: Leaking vials"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility: Leaking vials
May 23, 2024
Jun 05, 2024
13,880 vials
Recall Profile & Regulatory Data
Event ID
94686
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Batch or Lot Expiration Information
Lot# : G3000010, Exp. Date 11/2025
Affected Packages Involved in this Recall
55111-688-52Product
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
59,468 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, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Batch or Lot Expiration Information
Batch# Batch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020..
Affected Packages Involved in this Recall
55111-688-52Product
March 2016 Class II Recall: Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Recall Number
Class II Terminated
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Mar 03, 2016
Apr 06, 2016
3,342 vials
Recall Profile & Regulatory Data
Event ID
73527
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 03, 2017
Product Description
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Batch or Lot Expiration Information
Lot# Lot BS523, exp 10/2017
Affected Packages Involved in this Recall
55111-688-52Product
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.
