Drug recall
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100…
FDA recall event 85054 · Class III · Breckenridge Pharmaceutical, Inc
Key facts
| Event ID | 85054 |
|---|---|
| Recall numbers | D-1063-2020 |
| Recalling firm | Breckenridge Pharmaceutical, Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. |
| Initiation date | Feb 24, 2020 |
| Report date | Mar 4, 2020 |
| Termination date | Aug 31, 2020 |
| City | Berlin |
| State | CT |
| Country | United States |
| FEI number | 3006362554 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: