FDA recall D-1063-2015

Product

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

Reason for recall

Subpotent Drug

Distribution

Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2015-04-29

Report date

2015-05-20

Termination date

2018-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Titusville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2015