Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.
- 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:
- Teva Pharmaceuticals USA, Inc.
- Reason for Recall:
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Product Codes/Lot Numbers:
Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-689-2013
Related Recalls
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
CGMP Deviations: use of an unapproved raw material