Breckenridge Pharmaceutical, Inc recalls Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single…

Recall date

February 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1063-2020

FDA classification

Class III

Brand / firm

Breckenridge Pharmaceutical, Inc

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.