A prescription drug got recalled for ‘super potency.’ Patients have had problems
Rare is the prescription drug that gets recalled for super potency, but that’s the reason a thyroid drug got pulled Friday.
Acella Pharmaceuticals’ FDA-posted recall notice says testing determined 13 lots of its NP Thyroid tablets in 30 mg, 60 mg and 90 mg strengths were super potent. The notice also admitted Acella has heard of two patient adverse events “known to be related to this recall.”
NP Thyroid deals with underactive thyroid, a condition also known as “hypothyroidism.” Super potent NP Thyroid can cause an overactive thyroid.
The effects of that, the notice says, “include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances.”
Pregnant women can suffer miscarriages or “impairment to fetal development.”
The recalled lots are:
▪ 30 mg — M329A19-1, exp. 20-Dec.; M329H18-1, exp. 20-Jul.; M329J18-1, M329J18-2, M329J18-3, exp. 20-Aug.; M329M18-2, exp. 20-Nov.
▪ 60 mg — M330J18-2A, M330J18-3, exp. 20-Aug.
▪ 90 mg — M331G18-1, exp. 20-Jun.; M331J18-1, M331J18-2, exp. 20-Aug.; M331M18-1, M331M18-2, exp. 20-Nov.
Acella recommends talking to your prescribing doctor or a healthcare professional about a different treatment before halting NP Thyroid.
Those with questions about the recall can contact Acella via email at recall@acellapharma.com or phone at 800-541-4802, Monday through Thursday, 9 a.m. to 5 p.m., and Friday, 9 a.m. to 12:30 p.m.
To report problems with this or any drug, go to the adverse event reporting part of the FDA website or call 800-332-1088 to ask for a reporting form.
This story was originally published May 24, 2020 at 7:02 AM with the headline "A prescription drug got recalled for ‘super potency.’ Patients have had problems."
