FDA-Drug2018-10-03Class III
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
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
59,468 vials
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2019Don't want to check this manually?
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