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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description 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
Recall Number D-496-2013
Classification Class III
Code Info NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
Product Distributed Qty 17,108 blister packs
Reason For Recall Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

Event Detail

Event Id 64608
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide