Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 04
Recalled October 3, 2018 · FDA recall D-0103-2019 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradation Specifications: OOS for unknown impurities. · FDA Class III
Units
59,468 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, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →