Drug recall D-1063-2015

Class II Terminated reported May 20, 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

Lots and codes

Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)

Recall details

Recalling firm
Janssen Pharmaceuticals, Inc., Titusville, NJ
Quantity
16,861 cartons/6 blister units (28 tablets) each
Distribution
Nationwide and Canada
Type
Voluntary: Firm initiated
Recall initiated
April 29, 2015
Terminated
July 13, 2018