Class III
Terminated
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.
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- February 24, 2020
- Posted
- March 4, 2020
- Recall Number
- D-1063-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 900 Vials
- Firm Location
- Berlin, CT, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
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