Food And Drug Administration Issues Product Recall For Thyroid Medication Over Low Drug Levels

Acella Pharmaceuticals has issued a recall for its thyroid medication because it may not be as potent as is needed to treat hypothyroidism, which has prompted four reports of adverse effects from the drug.

The recall affects both 15 mg and 120 mg NP Thyroid tablets, which were found during testing by the U.S. Food and Drug Administration to only have 87% of the active ingredient levothyroxine, which may not be effective in treating an underactive thyroid. The medication also includes the drug liothyronine.

The affected medication was sold in 100 count bottles. The 15 mg tablets have an NDC number of 42192-327-01 with a lot code of M327E19-1. Expiration date is October 2020. The 120 mg tablets have an NDC number of 42192-328-01 and a lot code of M328F19-3. Expiration date is November 2020.

The medication was distributed nationwide. Labels of the thyroid medication can be viewed here.

Individuals that are taking the affected medication should continue to do so. They should contact their healthcare provider for further guidance and a replacement prescription. Anyone that experiences adverse reactions to the recalled thyroid medication should contact their healthcare provider as well.

Questions about the recall can be directed to Acella Pharmaceuticals at 1-888-280-2044, Monday through Friday from 8 a.m. to 5 p.m. EDT or by email at recall@acellapharma.com.

Those that take the thyroid drug may experience symptoms that include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland, and unexplained weight loss or difficulty losing weight.

There is also a serious risk from the medication in newborn infants or pregnant women with hypothyroidism, which could include miscarriage, fetal hyperthyroidism, or impairments to neural and skeletal development in infants. The elderly and people with underlying cardiac disease may also experience cardiac pain, palpitations, or cardiac arrhythmia.

The recall from Acella Pharmaceuticals follows an earlier recall by RCL Labs Inc. for 483 lots of Nature-Thyroid and WP Thyroid medication in all strengths, counts, and expiration dates because it also had low levels of liothyronine or levothyroxine.