Drug 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
D-689-2013
Product summary
- Event
- Event 64643
- Status
- Terminated
- Classification
- Class III
- Quantity
- 154,536 cartons
- Official record key
drug-enforcement:D-689-2013
Official wording
Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Code information: 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.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specification