Drug 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
D-0088-2024
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 93202
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 864 cartons
- Official record key
drug-enforcement:D-0088-2024
Official wording
Reason: 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.
Code information: Lot # 1187435 exp date: 02/2024
Distribution pattern: Distributed in the US. No government or foreign consignees.
Derived failure modes
-
Labeling or packaging
Labeling: Wrong