Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What was recalled
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
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0074-0038-28
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0403-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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