Abbott Laboratories' (>> Abbott Laboratories) former pharmaceutical unit, now spun off as AbbVie Inc. (>> AbbVie Inc), recently recalled more than 28,520 bottles of the thyroid-hormone replacement therapy Synthroid over a dose mix-up, marking the second recall of the drug in six months.
One lot of 150-microgram Synthroid tablets was recalled because one bottle was found to contain lower-dose, 75-microgram tablets, AbbVie spokesman Gregory Miley said Friday. The voluntary recall was initiated in early December as a precaution, he said.
The cause was a "manufacturing line clearance error," he said, and AbbVie has taken corrective action. The company isn't aware of any increase in patient complaints or adverse events associated with the label error.
AbbVie 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.
In July, Abbott recalled 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 a majority of them remained under Abbott's control and weren't shipped out.
Both Synthroid recalls were classified by the FDA as Class II, which is typically applied in situations where a product might cause a temporary health problem or pose only a slight threat of a serious health problem.
Synthroid is a synthetic thyroid hormone used by people with hypothyroidism, in which the thyroid gland doesn't produce enough natural thyroid hormone.
Abbott reported $461 million of global Synthroid sales for the first nine months of 2012.
AbbVie shares were recently down a penny at $33.61.
Write to Peter Loftus at [email protected]
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