FDA recall D-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

Reason for recall

Lack of Assurance of Sterility: Leaking vials

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-05-23

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2024