'Superpotent' Lots of NP Thyroid for Hypothyroidism Recalled in US

Disclosures

May 27, 2020

Acella Pharmaceuticals has voluntarily recalled 13 lots of its NP Thyroid medication, a combination of levothyroxine (T4) and liothyronine (T3) prescribed for hypothyroidism, because the company says testing has revealed the affected pills may be "superpotent" with up to 115% of the labeled amount of liothyronine.

The US Food and Drug Administration (FDA) has been informed and issued a statement to the same effect, noting that, as of May 26, "Acella has received two reports of adverse events known to be related to this recall."

Those being treated for hypothyroidism who take one of these "superpotent" pills may experience signs and symptoms of hyperthyroidism, such as weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances, the company warns.

It also says pregnant women who take the affected medication could "experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development."

But the company stresses that patients should not stop taking NP Thyroid without first talking to their healthcare professional "for further guidance and/or a replacement prescription."

The recall affects 13 lots of 30-mg, 60-mg, and 90-mg tablets, which came in 100-count bottles. Lot numbers are:

  • NP Thyroid 30 mg: Lot M329A19-1 expiration 20-Dec, lot M329H18-1 expiration 20-Jul, lot M329J18-1 expiration 20-Aug, lot M329J18-2 expiration 20-Aug, lot M329J18-3 expiration 20-Aug, lot M329M18-2 expiration 20-Nov.

  • NP Thyroid 60 mg: Lot M330J18-2A expiration 20-Aug, lot M330J18-3 expiration 20-Aug.

  • NP Thyroid 90 mg: Lot M331G18-1 expiration 20-Jun, lot M331J18-1 expiration 20-Aug, lot M331J18-2 expiration 20-Aug, lot M331M18-1 expiration 20-Nov, lot M331M18-2 expiration 20-Nov.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. And more information can be found here.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and Facebook.

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