Acella Pharmaceuticals announced the voluntary recall of 13 lots of NP Thyroid® (thyroid tablets) 30mg, 60mg and 90mg due to super potency. Testing revealed that the product may have up to 115% of the labeled amount of Liothyronine (T3) (acceptable range is 90.0-110.0%).
The 13 recalled lots of NP Thyroid 30mg (NDC 42192-329-01), 60mg (42192-330-01) and 90mg (42192-331-01) were distributed nationwide in 100-count bottles. A complete list of the recalled products, including expiration dates and lot numbers, can be found here.
NP Thyroid is indicated for the treatment of hypothyroidism, and consists of levothyroxine and liothyronine. Use of the recalled product may lead to signs and symptoms of hyperthyroidism. In a statement, the Company also noted that “pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development.”
At this time, Acella has received 2 reports of adverse events related to this recall, however the Company urges that patients contact their healthcare providers before discontinuing treatment. Adverse reactions should be reported to the FDA’s MedWatch program.
For more information regarding this recall, contact Acella Pharmaceuticals at (800) 541-4802 or visit acellapharma.com.