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Recall Observatory FDA recall evidence

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

March 14, 2013

Class III

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurity/Degradation Specification