FDAClass IIJune 5, 2024

Zoledronic Acid Injection 5mg/100mL Sterile Solution recall: Sterility Concern

Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…

Why was Zoledronic Acid Injection 5mg/100mL Sterile Solution recalled?

Lack of Assurance of Sterility: Leaking vials

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: G3000010, Exp. Date 11/2025

Product
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
13,880 vials
Distribution
Nationwide within the United States
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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