To assist you in the care of your patients, we would like to alert you to the recall of 13 lots of 30 mg, 60 mg and 90 mg NP Thyroid® , opens new window (thyroid tablets, USP), packaged in 100-count bottles, on May 22, 2020.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall. We have listed alternative options below.

The drug manufacturer, Acella Pharmaceuticals, is voluntarily recalling these products because testing has found these lots to be super potent—i.e., contain up to 115% of the labeled amount of liothyronine (T3). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

NP Thyroid contains levothyroxine and liothyronine, which treat hypothyroidism (underactive thyroid). Patients who receive super-potent NP Thyroid may experience signs and symptoms of hyperthyroidism (overactive thyroid), which 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 also may experience negative maternal and fetal outcomes, including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professionals before they stop taking their NP Thyroid medication. To date, Acella has received two reports of adverse events related to this recall.

Medications included in this recall:

Product name NDC number Lot number Expiration date NP Thyroid 30 mg 42192-0329-01 M329A19-1 12/20/2020 NP Thyroid 30 mg 42192-0329-01 M329H18-1 07/20/2020 NP Thyroid 30 mg 42192-0329-01 M329J18-1 08/20/2020 NP Thyroid 30 mg 42192-0329-01 M329J18-2 08/20/2020 NP Thyroid 30 mg 42192-0329-01 M329J18-3 08/20/2020 NP Thyroid 30 mg 42192-0329-01 M329M18-2 11/20/2020 NP Thyroid 60 mg 42192-0330-01 M330J18-2A 08/20/2020 NP Thyroid 60 mg 42192-0330-01 M330J18-3 08/20/2020 NP Thyroid 90 mg 42192-0331-01 M331G18-1 06/20/2020 NP Thyroid 90 mg 42192-0331-01 M331J18-1 08/20/2020 NP Thyroid 90 mg 42192-0331-01 M331J18-2 08/20/2020 NP Thyroid 90 mg 42192-0331-01 M331M18-1 11/20/2020 NP Thyroid 90 mg 42192-0331-01 M331M18-2 11/20/2020

Recommendations:

To reduce impact to your patients, please consider the listed alternative options below. (Please note that 15 mg and 120 mg NP Thyroid tablets are unaffected by this recall.)

Preferred alternatives levothyroxine tablets (all strengths) liothyronine tablets (all strengths)

Information for providers:1

  • We have sent a letter to your patients who have had a claim for NP Thyroid and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • Healthcare providers with questions can contact Acella Customer Service at 1-800-541-4802, Monday – Thursday, 9 a.m. – 5 p.m., and Friday, 9 a.m. – 12:30 p.m., Eastern time; or email recall@acellapharma.com.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    • Online: Complete and submit the report, opens new window
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form, opens new window
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 1-800-FDA-0178.

Reference:

  1. “Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency.” U.S. Food and Drug Administration. May 22, 2020. www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid , opens new window