AbbVie Inc., an Abbott Laboratories spin-off, has recalled more than 28,520 bottles of the thyroid-hormone replacement therapy Synthroid over a labeling error. It is the second recall of the drug in six months.
Synthroid is a synthetic thyroid hormone used to treat hypothyroidism, when the thyroid gland doesn't produce enough natural thyroid hormone.
One lot of 150-microgram Synthroid tablets was recalled because a bottle was found to contain a lower dose, AbbVie spokesman Greg Miley said Friday. The voluntary recall began in early December, when AbbVie was still part of Abbott.
The company said it was due to a manufacturing error and has taken corrective action. AbbVie isn't aware of any increase in patient complaints or adverse events associated with the error.
AbbVie, based in North Chicago, Ill., was spun off to Abbott shareholders as an independent company at the start of January. AbbVie assumed Synthroid's U.S. marketing rights, though Abbott Labs continues to market the drug outside the U.S.
The recent recall follows one in July by Abbott which included three lots of Synthroid because some bottles had defects that could affect the stability of the tablets at the end of shelf life. More than 136,500 bottles of Synthroid were subject to that recall, though Abbott said most of them weren't shipped out.
- Pharmaceuticals & Drug Trials
- Abbott Laboratories