Seasonale(R) recall: Impurity Out of Spec
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women…
Why was Seasonale(R) recalled?
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
- 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…
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Quantity
- 17,108 blister packs
- Distribution
- Nationwide
- Recall date
- June 5, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)