Voluntary Recall Information

September 29, 2020

Dear Valued RLC Client,

In our attempt to provide periodic updates regarding our recall, please see below.

In correspondence from FDA dated September 22, 2020, the Agency stated:

The Food and Drug Administration (FDA) agrees with your voluntary recall of the lots listed in the table below of Nature-Throid, Thyroid USP Tablets and WP Thyroid, Westhroid Pure, USP Tablets, [liothyronine (T3) and levothyroxine (T4)], packaged in 30-count, 60-count, 90-count, 100-count, and 1000-count bottles. These products are being recalled because FDA analysis found that the liothyronine (T3) and/or the levothyroxine (T4) component of the product to be subpotent.

Product Name	Lot Number	Expiration Date	NDC Code	Container Size
WP Thyroid (Thyroid USP) ½ Grain (32.5MG)	119142	01/2022	64272-5550-4 64727-5500-6 64727-5500-1	30 count bottles 90 count bottles 100 count bottles
Nature-Throid (Thyroid USP) ½ Grain (32.5 MG)	099186	11/2022	64727-3299-6 64727-3299-1	90 count bottles 100 count bottles
Nature-Throid (Thyroid USP) ¾ Grain (48.75MG)	109242	11/2022	64727-3302-1 64727-3302-2	100 count bottles 1000 count bottles
Nature-Throid (Thyroid USP) 1.25 Grain (81.25MG)	109032	10/2022	64727-3303-1	100 count bottles
Nature-Throid (Thyroid USP) 1.5 Grain (97.5 MG)	109286	10/2022	64727-3305-4 64727-3305-5 64727-3305-6 64727-3305-1	30 count bottles 60 count bottles 90 count bottles 100 count bottles
Nature-Throid (Thyroid USP) 2 Grain (130 MG)	109264	10/2022	64272-3308-4 64727-3308-1	30 count bottles 100 count bottles

FDA Recall

RLC Labs® has initiated a voluntary recall at the request of the FDA. In addition to issuing the voluntary recall for the 6 lots identified by FDA as sub-potent listed above, per FDA recommendation, we made the decision to pull all unexpired product to ensure that all product currently in distribution meets top quality and safety standards.

Recall Update

On August 25, 2020, RLC Labs made the difficult, but we felt necessary, decision to issue a voluntary recall of all unexpired lots of Nature-Throid® and WP Thyroid® at the request of the FDA. The recall extends to 483 lot numbers, dating back to 2017. This voluntary recall is being conducted because we were notified by the FDA that samples from 5 lots of Nature-Throid® and 1 lot of WP Thyroid® were tested and found to contain less than the required 90% of the active ingredient (note that, in each case, the FDA-tested products contained no less than 87% of the active ingredient).

On September 25, 2020, the FDA notified RLC Labs that only the 6 lot numbers listed above need to be recalled to the consumer level, as these are the main concern of the FDA. Product from the remaining 477 lots are still being voluntarily recalled by RLC Labs to the distribution level (rather than the consumer level). The FDA has concluded that product from the additional lots is unlikely to cause serious health consequences.

RLC Labs Update

Upon learning of the situation, RLC Labs moved swiftly to employ the help of top FDA experts in exploring every possible option to make the improvements to our quality system for manufacturing product that are necessary to ensure that all product we distribute meets our high standards. RLC Labs embraces our continued vision to be the leading manufacturer of natural thyroid medication. We have always strived to provide the highest quality thyroid medications and to be the industry leader.

RLC Labs continues to work diligently with leading quality, compliance and regulatory consulting firms consisting of top engineers, scientists and specialists. Over the past few weeks, we have strategized with this team of experts to create custom solutions and our plan for implementing necessary changes.

Although we do not yet have an exact timeframe for the reintroduction of Nature-Throid and WP Thyroid, we will continue to work with our team and FDA to ensure that the products are back on the market as soon as possible.

We will be sharing all updates as they continue to be available. Our heartfelt thanks to all of you who continue to stand by us. Your notes of encouragement, support, and kind gestures have had an enormous positive impact on all of us at RLC Labs. We could not make this happen without all of you!

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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