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
Reported: June 5, 2024 Initiated: May 23, 2024 #D-0510-2024
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
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 13,880 vials
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 13,880 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Leaking vials
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2024. Severity: Moderate. Recall number: D-0510-2024.
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