Recalls / Class II
Class IID-0510-2024
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
- Brand name
- Zoledronic Acid
- Generic name
- Zoledronic Acid
- Active ingredient
- Zoledronic Acid
- Route
- Intravenous
- NDC
- 55111-688
- FDA application
- ANDA091363
- Affected lot / code info
- Lot #: G3000010, Exp. Date 11/2025
Why it was recalled
Lack of Assurance of Sterility: Leaking vials
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 13,880 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-23
- FDA classified
- 2024-05-28
- Posted by FDA
- 2024-06-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0510-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.