FDA recall D-1063-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-02-24

Report date

2020-03-04

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2020