Drug product
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
D-496-2013
Product summary
- Event
- Event 64608
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,108 blister packs
- Official record key
drug-enforcement:D-496-2013
Official wording
Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Code information: NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specification