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.

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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.

12 Comments

  • SabrinaMarch 21, 2022 at 4:44 pm

    I was taking Nature Throid for a long time. I have no thyroid and rely completely on the potency of the medication. I had a TSH of 13 for an unknown length of time. I am now on NP Thyroid and it makes me very nauseated and I have severe abdominal pain everyday. I have co tinued to decli e rapidly and spending a lot of time and money on trying to figure out what is wrong with me. I have lost m[Show More]I was taking Nature Throid for a long time. I have no thyroid and rely completely on the potency of the medication. I had a TSH of 13 for an unknown length of time. I am now on NP Thyroid and it makes me very nauseated and I have severe abdominal pain everyday. I have co tinued to decli e rapidly and spending a lot of time and money on trying to figure out what is wrong with me. I have lost my career of 33 years and have no income and no where to turn while I wait on SS disability approval. I have worked as a Firefighter Paramedic, FF Instructor and have always been strong and able to do about anything I needed to. Now I can barely walk, dress myself, or do anything with my arms and hands. It is like I have MS yet the doctors cannot figure out what is wrong. Is there any help for those of us very likely affected by taking the RX that had no potency for an unknown length of time?

  • CindyDecember 22, 2021 at 4:35 pm

    I've been on Nature-Throid since my thyroidectony in 2010 & have had absolutely NO problems. My doctor now has me on NP Thyroid & that brand doesn't agree with me for some reason. I've had poor sleep & what feels like anxiety. I even had a stress test a few weeks ago because I didn't know if it was related to cardiac issues, which it wasn't. Two weeks ago I cut my dose in half & the feeling of anx[Show More]I've been on Nature-Throid since my thyroidectony in 2010 & have had absolutely NO problems. My doctor now has me on NP Thyroid & that brand doesn't agree with me for some reason. I've had poor sleep & what feels like anxiety. I even had a stress test a few weeks ago because I didn't know if it was related to cardiac issues, which it wasn't. Two weeks ago I cut my dose in half & the feeling of anxiety has let up, but I'm still not sleeping well. BRING BACK NATURE-THROID!!!!!

  • DanaOctober 18, 2021 at 12:09 pm

    I had been on NP Thyroid for months before being told the medication was “substandard” and being recalled. I lost my job and now seeking disability. I’d like to speak to a lawyer about this. One that can work with claimants in New Mexico.

  • KellyAugust 2, 2021 at 2:27 pm

    Nature-thyroid is the only medication that worked for me. I’ve been struggling since the recall. I tried NP Thyroid and it wasn’t working, I had terrible stomach pain everyday and GI issues. Now, my last choice is Armour, for me, it’s not as effective as Nature-thyroid but it’s the only choice I have before going to the compound pharmacy but they are expensive. It’s unfortunate that big pharma wil[Show More]Nature-thyroid is the only medication that worked for me. I’ve been struggling since the recall. I tried NP Thyroid and it wasn’t working, I had terrible stomach pain everyday and GI issues. Now, my last choice is Armour, for me, it’s not as effective as Nature-thyroid but it’s the only choice I have before going to the compound pharmacy but they are expensive. It’s unfortunate that big pharma will destroy a small company that makes a medication that has helped so many. This has been a struggle and my health and well being compromised. The lawsuits against RLC will only harm us, it’s unfortunate.

  • TerriJuly 5, 2021 at 1:24 pm

    Follow the money as expressed by Angela. I, too, am fearful that Nature-throid will not come back due to Abbvie's powerful lobbying. Should neither Acella or RLC return to the market, Abbvie will have a lock up on the thyroid market. After years of uenlightened treatment by physicians for my Hashimoto's, research lead me to NDT alternatives(Armour did not work for me). I am, now, on T4/T3 syn[Show More]Follow the money as expressed by Angela. I, too, am fearful that Nature-throid will not come back due to Abbvie's powerful lobbying. Should neither Acella or RLC return to the market, Abbvie will have a lock up on the thyroid market. After years of uenlightened treatment by physicians for my Hashimoto's, research lead me to NDT alternatives(Armour did not work for me). I am, now, on T4/T3 synthetics - cannot optimize and I feel it, everyday Complain to FDA We should be allowed to have a choice in meds

  • RhondaJune 9, 2021 at 8:41 pm

    It is difficult to keep up with all that the FDA is doing, but here is something everyone should know. The FDA has now categorized Natural Desiccated Thyroid as a Biological Drug from a thyroid drug, which means they have to change their manufacturing process, buy new equipment. As stated by Angela, this company is very small and I doubt we will ever see Nature-throid back on the market. HERE IS F[Show More]It is difficult to keep up with all that the FDA is doing, but here is something everyone should know. The FDA has now categorized Natural Desiccated Thyroid as a Biological Drug from a thyroid drug, which means they have to change their manufacturing process, buy new equipment. As stated by Angela, this company is very small and I doubt we will ever see Nature-throid back on the market. HERE IS FOOD FOR THOUGHT: RLC Labs and Acella Pharma makers of NP are the ONLY 2 companies who received these warning letters. ARMOUR thyroid Did Not, and WHY? Because they are backed by BIG pharma, AbbVie/Allergan who already have the manufacturing processes in place and a legal team with knowledge of the hoops a company has to go through with Biologics, i.e. patents, licenses, etc. Armour is Not for me, but I'm still taking it. I was ready to jump to NP when they had their last recall in April. However, I did speak with one of their pharmacists who assured me they would be selling their product, said he couldn't tell me how he knew this. I've never tried NP but I'm hoping it's better than Armour. I am currently working on obtaining information from the FDA regarding Compounding pharmacies that use the same porcine ingredients but they have not been called biologics, yet! I'm sorry for anyone who feels that Natural Desiccated Thyroid has caused so many problems, but I have been on the synthetics and will stick with NDTs as long as I can.

  • NicoleJune 3, 2021 at 1:23 am

    I also had sevrere side effects from this medication, and I have been confirmed by RITE AID that i was dispatched medicaation from the recalls. I was in the ER and had a catscan as I had such severe constipation. The fatigue was terrible, and I lost work because of these sympyoms. Is there any legal action to take? Thanks

  • zulmaJune 2, 2021 at 5:15 am

    I'm so glad I did stopped taking levothyroxine I went through a lot of pain u guys don't have and Idea Please don’t take the medicine anymore

  • LindaMay 19, 2021 at 7:14 pm

    I became near death because of the subdosing during the pandemic. I literally passed out on the sidewalk for a few seconds when my hormones hit bottom. You can find doctors that can have nature throid compounded by the pharmacy. I have been doing this since last September. It is a long hard road to get your dose right. You have to keep it refrigerated and it costs about $40 per month. I have no th[Show More]I became near death because of the subdosing during the pandemic. I literally passed out on the sidewalk for a few seconds when my hormones hit bottom. You can find doctors that can have nature throid compounded by the pharmacy. I have been doing this since last September. It is a long hard road to get your dose right. You have to keep it refrigerated and it costs about $40 per month. I have no thyroid. This medicine was my last hope. Can't absorb synthetic hormones. I literally saw my death before me. Never never give up!

  • SarahFebruary 22, 2021 at 5:17 pm

    I am 100% in agreeance with Angela! I was on almost every kind of thyroid medication after my total thyroidectomy in 2011. In 2015 I was switched to Nature-Throid and I thrived on that for years. I am on NP Thyroid which is made by the same companies that made Armour and Synthroid and I'm struggling bad. I even had to go on FMLA at work because of my symptoms. Really hoping they can get back into [Show More]I am 100% in agreeance with Angela! I was on almost every kind of thyroid medication after my total thyroidectomy in 2011. In 2015 I was switched to Nature-Throid and I thrived on that for years. I am on NP Thyroid which is made by the same companies that made Armour and Synthroid and I'm struggling bad. I even had to go on FMLA at work because of my symptoms. Really hoping they can get back into production soon because I need that medication to live and it was the only one where I felt like I could actual live life and not be a shell of who I used to be before my thyroid issues started.

  • AngelaJanuary 22, 2021 at 5:53 am

    I've kept up with all of RLC's struggles to secure porcine thyroid, and keep the cost of the medication at a low price to the patient. I have little compassion for people who complain about how much other brands cost, and then codemn the brand that is least expensive. I am heart broken about the lawsuit; this isn't some giant PharmaCorp. They don't make anything but thyroid and adrenal support. [Show More]I've kept up with all of RLC's struggles to secure porcine thyroid, and keep the cost of the medication at a low price to the patient. I have little compassion for people who complain about how much other brands cost, and then codemn the brand that is least expensive. I am heart broken about the lawsuit; this isn't some giant PharmaCorp. They don't make anything but thyroid and adrenal support. And now a bunch of money grubbing malcontents are putting my life in danger, for their profit. Yes, I had some low thyroid symptoms, but nothing I thought I should worry about. I'm looking at my death, if we cannot get Naturthroid back in production sooner than later. My tissues do not recognize the synthetic thyroid hormones, so I don't get any into my tissues. With all the monkeying with Armour's binders and fillers, that makes me violently ill. I'm currently on NP thyroid, and I'm not absorbing it very well. I have no thyroid, so without a replacement that my body recognizes and can utilize, I will die. I am hoping, against all hope, that RLC can get production back up and running for NaturThroid and WestThroid. This company saved my life, and I won't have one, without them.

  • ErinNovember 3, 2020 at 10:22 pm

    Hello, I have had severe problems with Hypothyroidism, I have had to change to several different medications and dosages. Until I found Nature-Throid. Although the dosage took a while to controlled it was the best I’ve ever felt (with reference to the Hypothyroidism symptoms). Since the recall my Dr. placed me on Armor (too expensive way too expensive) and unfortunately symptoms have bee[Show More]Hello, I have had severe problems with Hypothyroidism, I have had to change to several different medications and dosages. Until I found Nature-Throid. Although the dosage took a while to controlled it was the best I’ve ever felt (with reference to the Hypothyroidism symptoms). Since the recall my Dr. placed me on Armor (too expensive way too expensive) and unfortunately symptoms have been exacerbated and thoughts of suicide and anger issues have grown. I’m always wonder what the new day will bring or even if I’ll make it through the day. Something needs to be done to this company with regards to sanctions, lawsuits whatever. We should not have to be put through this as patience because of their lack of professionalism and care. Just thoughts from one person who just can’t understand why they can get away with “patient abuse”.

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