FDA Drug recall 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 Cart…
- FDA Drug
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Cart… by Breckenridge Pharmaceutical, citing failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1063-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-02-24 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Identifiers
| code_info | Lot # 5553.044E; 5553.044F, Exp. 04/30/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1063-2020%22
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