Janssen Pharmaceuticals, Inc.

FDA Regulatory Profile

Janssen Pharmaceuticals, Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 26 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0218-2019, Class II) was initiated on October 23, 2018.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
26
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0218-2019Class IIOrtho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mgOctober 23, 2018
D-0217-2019Class IIOrtho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch October 23, 2018
D-1063-2015Class IIOrtho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 activeApril 29, 2015
D-1514-2014Class IIRisperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals September 11, 2013