Recalls / Class III
Class IIID-0088-2024
Product
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
- Brand name
- Synthroid
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 0074-3727, 0074-4341, 0074-4552, 0074-5182, 0074-6594, 0074-6624, 0074-9296, 0074-7068, 0074-7069, 0074-7070 +2 more
- FDA application
- NDA021402
- Affected lot / code info
- Lot # 1187435 exp date: 02/2024
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.
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, North Chicago, Illinois 60064-1802
Distribution
- Quantity
- 864 cartons
- Distribution pattern
- Distributed in the US. No government or foreign consignees.
Timeline
- Recall initiated
- 2023-10-17
- FDA classified
- 2023-11-05
- Posted by FDA
- 2023-11-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0088-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.