Why it was recalled
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Product description
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Lot numbers, UPCs & expiration codes
Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Where it was sold
US Nationwide and Puerto Rico
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-304-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 15, 2013
- FDA report date
- May 8, 2013
- Quantity
- 17,136 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Warner Chilcott Company LLC
Original FDA data
Every field from FDA enforcement report D-304-2013, exactly as published.
Show all FDA fields
- City
- Fajardo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 64459
- Address
- Road 195, Km 1.1
- Address (line 2)
- Union Street
- Code information
- Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
- Postal code
- 00738
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-304-2013
- Classification
- Class III
- Recalling firm
- Warner Chilcott Company LLC
- Product quantity
- 17,136 bottles
- Termination date
- Jun 9, 2014
- Reason for recall
- Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
- Distribution pattern
- US Nationwide and Puerto Rico
- Recall initiation date
- Feb 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 30, 2013