FDA-Drug2024-06-05Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

Lack of Assurance of Sterility: Leaking vials

Sold states
Nationwide within the United States
Affected count
13,880 vials
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2024

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