FDA-Drug2018-10-03Class III
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Sold states
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Affected count
10,530 vials
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0104-2019Don't want to check this manually?
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