Drug product
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064
D-0403-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 cartons
- Official record key
drug-enforcement:D-0403-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 1120778
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations