Drug recall D-0403-2021
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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
1120778
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 210 cartons
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Orilissa – drug information
- NDC 0074-0039 Orilissa · Elagolix Sodium 200 mg/1 · AbbVie Inc.
- NDC 0074-0038 Orilissa · Elagolix Sodium 150 mg/1 · AbbVie Inc.