Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Janssen Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1125 Trenton-Harbourton Rd, N/A, Titusville, New Jersey 08560-1503
Distribution
- Quantity
- 16,861 cartons/6 blister units (28 tablets) each
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2015-04-29
- FDA classified
- 2015-05-11
- Posted by FDA
- 2015-05-20
- Terminated
- 2018-07-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1063-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.