Drug product
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
D-0510-2024
Product summary
- Event
- Event 94686
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,880 vials
- Official record key
drug-enforcement:D-0510-2024
Official wording
Reason: Lack of Assurance of Sterility: Leaking vials
Code information: Lot #: G3000010, Exp. Date 11/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility