Drug product
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67
D-1439-2014
Product summary
- Event
- Event 68610
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5265 blister packs
- Official record key
drug-enforcement:D-1439-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Code information: Lot 33805449A, Exp. 12/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification