Drug 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.
D-1063-2020
Product summary
- Event
- Event 85054
- Status
- Terminated
- Classification
- Class III
- Quantity
- 900 Vials
- Official record key
drug-enforcement:D-1063-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Code information: Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out-of-specification