FDA-Drug2020-03-04Class III
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Breckenridge Pharmaceutical, Inc
Hazard
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Sold states
Nationwide in the U.S.
Affected count
900 Vials
Manufactured in
15 Massirio Dr Ste 201, N/A, Berlin, CT, United States
Products
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2020Don't want to check this manually?
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