Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma
Recalled October 3, 2018 · FDA recall D-0104-2019 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradation Specifications: OOS for unknown impurities. · FDA Class III
Units
10,530 vials
Sold at
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Description
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Product
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
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →