Hospira Inc., A Pfizer Company
FDA Regulatory Profile
Summary
- Total Recalls
- 9 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0980-2017 | Class III | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufacture | July 6, 2017 |
| D-0898-2017 | Class II | Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lak | May 18, 2017 |
| D-0480-2017 | Class II | METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For | February 10, 2017 |
| D-0638-2017 | Class I | Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusi | January 24, 2017 |
| Z-1682-2017 | Class II | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids fo | December 30, 2016 |
| D-0096-2017 | Class II | Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, | September 16, 2016 |
| D-0097-2017 | Class II | Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx | September 16, 2016 |
| D-0218-2017 | Class I | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Fr | August 4, 2016 |
| Z-2790-2016 | Class II | Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037 | July 28, 2016 |