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Labeling error: Second recall of thyroid-hormone therapy drug

New Jersey and other users nationwide of the pharmaceutical drug Synthroid might want to pay close attention to drug company AbbVie Inc.'s recent voluntary recall of the thyroid-hormone replacement therapy.

Consumers using the product might experience a bit of déjà vu from AbbVie's announcement, given that the Synthroid recall is the second since last July.

That earlier recall involved three lots of Synthroid -- more than 136,500 bottles -- and underscored company concerns that the tablets were not sustaining their required stability as they neared their expiration dates owing to product defects. The "company" at that time was Abbott Laboratories, which spun off its pharmaceutical unit to AbbVie, an independent drug maker, in January of this year.

The instant recall, while smaller in scope, still stresses serious concerns. One lot of nearly 30,000 bottles is being recalled owing to a "manufacturing line clearance error" that resulted in a labeling mistake. Specifically, Synthroid tablets in one bottle that were stated as being 150-micgogram doses were in fact just half that dose. The medication error, if repeated on other labels, could obviously result in dosing complications for many consumers.

Abbott continues to sell Synthroid in overseas markets, while AbbVie has sole control over marketing rights in the United States. The drug is a high-selling offering, with Abbott reporting more than $465 million in global sales over the first three quarters of last year.

If you or a member of your family has been injured by an unsafe pharmaceutical product, please contact Breslin & Breslin for a free consultation.

Source: Wall Street Journal, "Former Abbott drug unit issues second Synthroid recall," Peter Loftus, Jan. 11, 2013

  • Product liability issues extend across a wide spectrum of concerns, ranging from manufacturing and design defects in automobiles and household goods to unsafe foods and, as noted in this blog post, potentially dangerous pharmaceutical drugs. Readers can learn more information by visiting our New Jersey Products Liability page.

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