Cardinal Health Inc. recalls Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0
Recalled June 2, 2021 · FDA recall D-0403-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
210 cartons
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →