D-1063-2020 Class III Terminated
FDA drug recall D-1063-2020 was initiated by Breckenridge Pharmaceutical, Inc on February 24, 2020 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. The recall status is terminated (terminated August 31, 2020). Affected quantity: 900 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2020
- Initiation Date
- February 24, 2020
- Termination Date
- August 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 Vials
Product Description
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 Pattern
Nationwide in the U.S.
Code Information
Lot # 5553.044E; 5553.044F, Exp. 04/30/2021