Drug recall
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only…
FDA recall event 84011 · Class II · Ingenus Pharmaceuticals Llc
Key facts
| Event ID | 84011 |
|---|---|
| Recall numbers | D-0146-2020 |
| Recalling firm | Ingenus Pharmaceuticals Llc |
| Product type | Drugs |
| Products | Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Crystallization: Presence of particulate matter identified as API crystallization |
| Initiation date | Oct 9, 2019 |
| Report date | Oct 23, 2019 |
| Termination date | Dec 1, 2020 |
| City | Orlando |
| State | FL |
| Country | United States |
| FEI number | 3008810101 |
At a glance
- 1–9 Products in this recall
- None 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: