Voluntary Recall Information

August 25, 2020

RLC Labs, Inc. is dedicated to the health and safety of our hypothyroid community. As our number one priority, we want to ensure that you are aware of our decision to issue a recall of all unexpired lots of Nature-Throid® (Thyroid USP Tablets) and WP Thyroid® (Thyroid USP Tablets) that are currently in commercial distribution. This recall has been initiated because testing found that certain lots of these products may be sub-potent (i.e. contain less than 90% of the labeled amount of liothyronine or levothryroxine).

We have voluntarily decided to recall all unexpired lots in the marketplace to ensure that patients only receive product that meets our high quality standards.

As of this release, we have not been notified of any adverse reactions from patients related to this recall of Nature-Throid® and/or WP Thyroid®. We are currently working in tandem with the FDA to ensure the quality and safety of our products.

You are encouraged to contact your prescribing health care provider to discuss next steps. If you are currently taking Nature-Throid® or WP Thyroid®, you should not discontinue use without contacting your doctor for further guidance and/or a replacement prescription.

We appreciate your understanding. If you would like to contact our team directly, you can do so at 877-797-7997 or through our website at https://getrealthyroid.com/contact-us.html

USES & SAFETY INFORMATION

Precautions

As with any prescription medication, talk to your doctor about any existing medical conditions, and let your doctor know immediately if you experience any side effects.

Tell your doctor if:

You have any food or medicine allergies.
You’re pregnant, trying to conceive, or breastfeeding.
You are taking any other prescription or over-the-counter medications, or if you start or stop any medications while on WP Thyroid® and Nature-Throid®.
You suffer from any medical conditions other than hypothyroidism, particularly heart disease, clotting disorders, or adrenal or pituitary gland problems.
You have diabetes. Monitor your blood and/or urinary glucose levels as directed by your doctor and immediately report any changes.
You’re taking anticoagulants (blood thinners).
Let your dentist know you are taking WP Thyroid® and Nature-Throid® before any surgery.
You experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives, skin rash or any other unusual medical event.

Warnings: Don’t Take For

Do not take WP Thyroid® and Nature-Throid® either alone or in combination with other medicines, for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of WP Thyroid® and Nature-Throid® within the typical range used for hormone replacement are not effective for weight loss. Larger doses may result in serious or even life-threatening effects, especially when used in combination with certain other drugs used to reduce appetite.
Do not take WP Thyroid® and Nature-Throid® for male or female infertility unless it is associated with hypothyroidism.
Do not take WP Thyroid® and Nature-Throid® if you have hyperthyroidism or are allergic to any of its ingredients.

Use WP Thyroid® and Nature-Throid® exactly as prescribed. Unless otherwise directed by your doctor, do not stop taking either medication or alter how often it’s taken. Many factors can contribute to the length of time symptoms are alleviated, though generally people feel an improvement within a few weeks. For some, though, improvement in symptoms may take up to three months. Your doctor will determine which dose is right for you. If any life changes or new symptoms occur, consult your doctor to adjust your dose. Continue to see your doctor until your dosage levels prove stable based on your lab work, then continue to see your doctor at their request. Thyroid replacement therapy is usually taken for life.

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USE

WP Thyroid® and Nature-Throid® are thyroid replacement medications, containing standardized (T4) and (T3) hormones, used to treat hypothyroidism naturally; except in cases of temporary hypothyroidism, which is usually associated with an inflammation of the thyroid gland (thyroiditis). Thyroid replacement medication needs to be taken as prescribed by your physician and is typically taken for life.

SAFETY CONSIDERATIONS

Do not take WP Thyroid® or Nature-Throid® either alone or in combination with other medicines for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of WP Thyroid® or Nature-Throid® within the typical range used for hormone replacement are not effective for weight loss. Larger doses may result in serious or even life-threatening effects, especially when used in combination with certain other drugs used to reduce appetite. Too much thyroid hormone may result in a hyperthyroid state.

USES & SAFETY INFORMATION

Precautions

As with any prescription medication, talk to your doctor about any existing medical conditions, and let your doctor know immediately if you experience any side effects.

Tell your doctor if:

You have any food or medicine allergies.
You’re pregnant, trying to conceive, or breastfeeding.
You are taking any other prescription or over-the-counter medications, or if you start or stop any medications while on WP Thyroid® and Nature-Throid®.
You suffer from any medical conditions other than hypothyroidism, particularly heart disease, clotting disorders, or adrenal or pituitary gland problems.
You have diabetes. Monitor your blood and/or urinary glucose levels as directed by your doctor and immediately report any changes.
You’re taking anticoagulants (blood thinners).
Let your dentist know you are taking WP Thyroid® and Nature-Throid® before any surgery.
You experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives, skin rash or any other unusual medical event.

Warnings: Don’t Take For

Do not take WP Thyroid® and Nature-Throid® either alone or in combination with other medicines, for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of WP Thyroid® and Nature-Throid® within the typical range used for hormone replacement are not effective for weight loss. Larger doses may result in serious or even life-threatening effects, especially when used in combination with certain other drugs used to reduce appetite.
Do not take WP Thyroid® and Nature-Throid® for male or female infertility unless it is associated with hypothyroidism.
Do not take WP Thyroid® and Nature-Throid® if you have hyperthyroidism or are allergic to any of its ingredients.

WP Thyroid® and Nature-Throid® Tablets ARE PRESCRIPTION MEDICATIONS. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.