Janssen Ortho L.L.C.

FDA Regulatory Profile

Janssen Ortho L.L.C. appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0115-2017, Class III) was initiated on October 19, 2016.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0115-2017Class IIIInvokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, FinOctober 19, 2016
D-0006-2015Class IIXarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, GurSeptember 17, 2014