Quality Problems At Plant That Made Recalled Thyroid Drug Highlighted in FDA Warning Letter

Federal investigators have identified multiple quality control violations at the manufacturing plant for certain thyroid medications, which were recalled last month for not being potent enough.

In a warning letter to RLC Labs on October 9, the FDA cited a number of violations of current good manufacturing practice (CGMP) regulations, including the failure to maintain procedures for production and process control, as well as failing to maintain records of the blending of active pharmaceutical ingredients for Nature-Throid and WP Thyroid medications.

The agency issued a Nature-Throid and WP Thyroid recall on September 3, affecting 500 lots of the thyroid drugs due to a lack of sufficient potency.

The impacted medications were prescribed to treat patients who suffer from hypothyroidism, which is a condition in which thyroid hormones disrupt the heart rate, body temperature, and all aspects of metabolism. Both Nature-Throid and WP Thyroid are designed to introduce synthetic thyroid hormone levels to reverse the signs and symptoms.

According to the warning letter, an inspection of the drug manufacturer’s facility between February and March identified a series of quality control issues which led to the agency discovering those potency problems.

Among other violations of the CGMP regulations, the FDA deemed the manufacturer’s response to the formal request for information as inadequate, and is requiring RLC Labs to correct the listed deficiencies.

During the inspection, officials collected ten samples covering several different strengths of WP Thyroid and Nature-Throid medications. Of those, six samples were found to be sub-potent for at least one of the two active ingredients, Liothyronine or Levothyroxine.

Drug samples were found to contain as low as 87% of the labeled amount of Liothyronine and Levothyroxine. Inspectors say these levels mean the strength, quality, or purity of the two medications fall below standards which could put patients at risk of serious and potentially life threatening injuries.

Subsequently, the RLC Labs, Inc. voluntarily issued a recall of 483 lots of Nature-Throid and WP Thyroid in all strengths. The medications subject to the recall were packaged in 30, 60, 90, 100 and 1,000 count bottles and were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies.

Officials warned that the use of the recalled medications could result in an under-dosing event that could increase the risk of serious injury in newborn infants or pregnant women with hypothyroidism including miscarriage, fetal hyperthyroidism and impairments to fetal skeletal development.

Elderly patients are also at an increased risk of injury from the recalled thyroid drugs, with officials warning those with underlying cardiac disease toxic cardiac manifestations could suffer from cardiac pain, palpitations or cardiac arrhythmia.

The FDA has ordered RLC Labs to provide a comprehensive assessment and remediation plan to make sure its quality control program is functioning effectively, as well as a comprehensive assessment of how it manages changes to production, and to make improvements to its cleaning validation program. The agency also recommended RLC labs hire a CGMP consultant.

The company has 15 days from receiving the letter to respond, or else it could face further actions, such as being denied federal contracts, having approvals for export certificates and new drug applications denied, and other actions.

Patients who are currently being prescribed Nature-Throid® and WP Thyroid® are being asked to consult with their healthcare provider if they have experienced any adverse side effects and to consult with their doctor for further guidance or alternative prescriptions.

Those with additional questions are being asked to contact RLC Labs, Inc. Customer Service at 1-877-797-7997, or email them at recall@rlclabs.com.