Drug product
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58
D-1438-2014
Product summary
- Event
- Event 68610
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1125 blister packs
- Official record key
drug-enforcement:D-1438-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Code information: Lot 33805325A, Exp.11/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification