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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Warner Chilcott Company LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-304-2013
Related Recalls
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.
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.
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Warner Chilcott Company
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles