Fresenius Kabi USA LLC (FK USA)
Fresenius Kabi USA LLC (FK USA) appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-200-2013, Class III) was initiated on February 1, 2013.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-200-2013 | Class III | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow | February 1, 2013 |
| D-915-2013 | Class II | IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactu | January 22, 2013 |