FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility: Leaking vials

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
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot #: G3000010, Exp. Date 11/2025

Units Affected

13,880 vials