Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product description
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
Lot numbers, UPCs & expiration codes
1120778
Where it was sold
FL, GA, SC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0403-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 210 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0403-2021, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 87512
- Address
- 7000 Cardinal Pl
- Code information
- 1120778
- Postal code
- 43017-1091
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0403-2021
- Classification
- Class II
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 210 cartons
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, GA, SC
- Recall initiation date
- Mar 15, 2021
- Initial firm notification
- Letter
- Center classification date
- May 24, 2021