D-0510-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2024
- Initiation Date
- May 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,880 vials
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
Reason for Recall
Lack of Assurance of Sterility: Leaking vials
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: G3000010, Exp. Date 11/2025