Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie I...

FDA Recall #D-0088-2024 — Class III — October 17, 2023

Recall #D-0088-2024 Date: October 17, 2023 Classification: Class III Status: Ongoing

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

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.

Recalling Firm

AbbVie Inc. — North Chicago, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

864 cartons

Distribution

Distributed in the US. No government or foreign consignees.

Code Information

Lot # 1187435 exp date: 02/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated