Thyroid Tablets
Superpotent Drug
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Synthroid Levothyroxine Sodium NDC 00074-7068 |
125 ug/1 | Tablet Oral |
AbbVie Inc. | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Superpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Failed Stability Specifications
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
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