Drug product
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
D-0428-2024
Product summary
- Event
- Event 94183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92,676 cartons
- Official record key
drug-enforcement:D-0428-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications