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
Reported: June 5, 2013 Initiated: March 14, 2013 #D-496-2013
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
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 17,108 blister packs
- Distribution
- Nationwide
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 17,108 blister packs.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2013. Severity: Low. Recall number: D-496-2013.
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