Janssen Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 26
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0217-2019 | Class II | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch | October 23, 2018 |
| D-0218-2019 | Class II | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg | October 23, 2018 |
| D-1063-2015 | Class II | Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active | April 29, 2015 |
| D-1514-2014 | Class II | Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals | September 11, 2013 |