Acella Recalls Hypothyroid Drug Over Subpotency Concerns
Specialty drug manufacturer Acella Pharmaceuticals is recalling dozens of lots of NP Thyroid tablets, a drug for treatment of hypothyroidism, after it was determined that the products did not meet potency standards, a recurring issue for the company that previously prompted FDA enforcement action.
The Alpharetta, Ga., company recalled a significant amount of product after routine testing determined dozens of lots were subpotent, pulling 35 commercial lots of 100-count NP Thyroid bottles and three lots of 7-count sample bottles in total. The FDA noted that Acella has received 43 reports of serious adverse events to date that may be linked to the substandard underactive thyroid drugs.
The underpowered tablets hold a significant risk for hypothyroidism patients, the agency said, including swelling of the thyroid gland, fatigue, depression, dry skin, puffy face, hair loss, slowed heart rate and other issues.