FDAFDA · Food and drugs·Recall number D-1063-2020
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.
Published March 4, 2020 · Recall initiated: February 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Distributor
- Nationwide in the U.S.
- Lot
- Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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