FDA warns more thyroid drugs recalled because they’re not potent enough

Brittany A. Roston - Sep 20, 2020, 12:18pm CDT
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FDA warns more thyroid drugs recalled because they’re not potent enough

On Thursday, September 17, the Food and Drug Administration brought attention to another voluntary recall of thyroid medication — and as with the previous recall, the drugs may be too weak to properly treat those who take them. This follows a similar recall of thyroid medications issued in recent weeks, though that one was issued for the opposite reason: the drugs were too potent, putting patients at risk of becoming hyperthyroid and developing the risks associated with that.

The voluntary recall comes from Acella Pharmaceuticals, which is recalling two lots of its NP Thyroid 15 and NP Thyroid 120 tablets because they may be sub-potent, meaning they may not have the number of thyroid hormones specified on the labels. Hypothyroidism patients who take sub-potent medication are at risk of falling back into the hypothyroid range and developing the related symptoms.

The recalled thyroid drugs are sold as 15mg and 120mg strengths; they contain both the T3 and T4 hormones for those who aren’t able to be treated with synthetic T4 hormone. Someone with hypothyroidism who takes these tablets may experience the return of symptoms if the actual hormone levels are lower than indicated. Symptoms may include fatigue, dry skin, depression, thyroid swelling, feeling cold, hair loss, puffy face, and more.

According to the company’s recall, which was highlighted by the FDA last week, Acella Pharmaceutical has received four reports of ‘adverse events’ that were potentially related to the drugs in the recalled lots. Both recalled products were sold in 100-tablet bottles; the 15mg strength has an expiration date of October 2020 and the 120-mg strength has a recall date of November 2020.

Consumers who take this brand of thyroid medication can find the other identification details, including NDC numbers, on the FDA’s website here.

The company says that these lots were distributed to healthcare offices, direct accounts, pharmacies, and more across the US. Acella notes that if you take NP Thyroid in these strengths and your product’s expiration date is on or after December 2020, the bottle is not included in this recall. Those who have recalled pills are advised to continue taking them and to get in contact with their doctor for advice on how to proceed and to get a new prescription.


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