FDA recall D-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

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.

Distribution

Distributed in the US. No government or foreign consignees.

Key facts

Status

Ongoing

Initiation date

2023-10-17

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2024