Reported May 20, 2015 · Terminated
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7…
Janssen Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Janssen Pharmaceuticals, Inc. · 1125 Trenton-Harbourton Rd · Titusville, NJ · 08560-1503
Is this the product you have?
- 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 byJanssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands
- Manufactured forJanssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15
- Lot codes and dates
Lot # 13CM724Exp.09/15 (US) Lot # (L) 13DM732Exp. 09/15 (Canada)
- Amount recalled
- 16,861 cartons/6 blister units (28 tablets) each
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug
This product could cause temporary or reversible health problems — stop using it.
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