Drug 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.
D-1063-2015
Product summary
- Event
- Event 71064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,861 cartons/6 blister units (28 tablets) each
- Official record key
drug-enforcement:D-1063-2015
Official wording
Reason: Subpotent Drug
Code information: Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Potency or specification failure
Subpotent