Drug product
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
D-683-2013
Product summary
- Event
- Event 64644
- Status
- Terminated
- Classification
- Class III
- Quantity
- 54,412 blister packs
- Official record key
drug-enforcement:D-683-2013
Official wording
Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Code information: NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.
Distribution pattern: Nationwide distribution. No foreign or government accounts.
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specification