Why it was recalled
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Product description
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Lot numbers, UPCs & expiration codes
Lot # 1187435 exp date: 02/2024
Where it was sold
Distributed in the US. No government or foreign consignees.
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-0088-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Oct 17, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 864 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc.
Original FDA data
Every field from FDA enforcement report D-0088-2024, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93202
- Address
- 1 N Waukegan Rd
- Code information
- Lot # 1187435 exp date: 02/2024
- Postal code
- 60064-1802
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0088-2024
- Classification
- Class III
- Recalling firm
- AbbVie Inc.
- Product quantity
- 864 cartons
- Reason for recall
- Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
- Distribution pattern
- Distributed in the US. No government or foreign consignees.
- Recall initiation date
- Oct 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2023