McKesson

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
5
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0353-2026Class IUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, ManufactuJanuary 16, 2026
D-0213-2025Class IIInflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx oJanuary 17, 2025
D-0005-2015Class IIAmiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured foSeptember 12, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K771175RESUSCITATOR, MS30August 2, 1977
K761196NITROUS OXIDE SCAVENGING MASKDecember 13, 1976
K761194HLR QUICK-FIT HEART-LUNG RESUSCITATORDecember 9, 1976
K761195ESOPHAGEAL OBTURATION AIRWAYDecember 9, 1976
K760017CONSIOUS SEDATION (ANALOR P-76)July 20, 1976