October 2023 FDA Recall Synthroid by Abbvie Inc.
D-0088-2024 - Labeling
This Class III drug recall was voluntarily initiated by Abbvie Inc. on October 17, 2023 for the product Synthroid. The FDA reported the reason for recall as labeling. The product was distributed in Distributed in the US. No government or foreign consignees. and the recall is currently ongoing.
Recall Number: D-0088-2024
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.
10-17-2023
11-15-2023
864 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AbbVie Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in the US. No government or foreign consignees.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 1187435 exp date: 02/2024
