Recalls / Class III
Class IIID-689-2013
Product
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
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 154,536 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-03-15
- FDA classified
- 2013-07-11
- Posted by FDA
- 2013-07-17
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-689-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.