Acella Issues Voluntary Recall of Two Lots of Thyroid Medication

Source: FDA

RECALL

Acella Pharmaceuticals announced Sept. 17 that it was voluntarily recalling one lot of 15mg and one lot of 120mg NP Thyroid, Thyroid Tablets, USP (levothyroxine, T4, and liothyronine, T3). These products are packed in 100-count bottles. Testing has found these lots to be subpotent.

Patients being treated for hypothyroidism who receive the subpotent medication may experience signs and symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland or unexplained weight gain or difficulty losing weight.

There is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism, including early miscarriage, fetal hyperthyroidism or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism my occur.

Affected NDCs, lot numbers and expiration dates are: NP Thyroid 15, Thyroid Tablets, USP, ¼ grain (15mg): NDC 42192-327-01. Lot M327E19-1. Expires October 2020. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120mg): NDC 42192-328-01. Lot M328F19-3. Expires November 2020.

Patients who are taking NP Thyroid from the recalled lots should not discontinue use without contacting their health care provider for guidance. Consumers with questions can email Acella at recall@acellapharma.com or call (888) 280- 2044, Monday-Friday, 8 a.m. to 5 p.m. Eastern. If consumers are experiencing any problems with these drugs, they should contact their health care provider.

Report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program.