← FDA ENFORCEMENT
D-0088-2024Class III

AbbVie Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AbbVie Inc.
Product type
Drug
Status
Ongoing
Report date
2023-11-15
Distribution
Distributed in the US. No government or foreign consignees.
Firm state
IL
Product quantity
864 cartons
Initiated by
Voluntary: Firm initiated
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.

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

Code / lot info

Lot # 1187435 exp date: 02/2024

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →