ALPHARETTA, Ga. — Acella Pharmaceuticals LLC on Friday issued a voluntary recall of certain varieties of a drug used to treat underactive thyroid because routine testing found some lots contained less than the prescribed amounts of active ingredients.
The recall affects 35 lots of the drug sold as NP Thyroid in a variety of strengths, as well as three sample lots.
Alpharetta, Georgia-based Acella has received 43 reports to date of serious adverse events that could possibly be related to the recall, the company said in a prepared statement, distributed Friday by the U.S. Food and Drug Administration.
According to the recall, the affected lots contain less than 90% of the labeled amount of liothyronine, or T3, and/or levothyroxine, or T4.
Patients being treated for underactive thyroid, or hypothyroidism, who receive weakened versions of Acella drug may experience signs and symptoms of hypothyroidism, including:
• increased sensitivity to cold
• dry skin
• puffy face
• hair loss
• slow heart rate
• swelling of the thyroid gland
• unexplained weight gain
• difficulty losing weight
In addition, Acella stated in the recall that there is a “reasonable risk of serious injury” in newborn infants or pregnant women experiencing hypothyroidism, including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development.
Meanwhile, toxic cardiac manifestations of hyperthyroidism such as cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease, the recall stated.
Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Consumers with questions about the recall can email Acella Pharmaceuticals at email@example.com or by calling 1-888-424-4341, Monday through Friday from 8 a.m. to 5 p.m. EDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, the recall stated.
Click here to see the complete lists of all 38 affected lots of the drug.
Cox Media Group