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FDAFebruary 24, 2020drug

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 2103...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

breckenridge pharmaceuticalbreckenridge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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