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.
Reported: May 20, 2015 Initiated: April 29, 2015 #D-1063-2015
Product Description
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
Details
- Recalling Firm
- Janssen Pharmaceuticals, Inc.
- Units Affected
- 16,861 cartons/6 blister units (28 tablets) each
- Distribution
- Nationwide and Canada
- Location
- Titusville, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Janssen Pharmaceuticals, Inc.. Units affected: 16,861 cartons/6 blister units (28 tablets) each.
Why was this product recalled? ▼
Subpotent Drug
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-1063-2015.
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