Why it was recalled
Subpotent Drug
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.
Lot numbers, UPCs & expiration codes
Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)
Where it was sold
Nationwide and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1063-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 29, 2015
- FDA report date
- May 20, 2015
- Quantity
- 16,861 cartons/6 blister units (28 tablets) each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1063-2015, exactly as published.
Show all FDA fields
- City
- Titusville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71064
- Address
- 1125 Trenton-Harbourton Rd
- Code information
- Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)
- Postal code
- 08560-1503
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1063-2015
- Classification
- Class II
- Recalling firm
- Janssen Pharmaceuticals, Inc.
- Product quantity
- 16,861 cartons/6 blister units (28 tablets) each
- Termination date
- Jul 13, 2018
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Apr 29, 2015
- Initial firm notification
- Center classification date
- May 11, 2015