RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid and WP Thyroid with Current Expiry Due to Sub Potency – FDA.gov


Posted: September 5, 2020 at 9:49 am

Summary Company Announcement Date: September 03, 2020 FDA Publish Date: September 03, 2020 Product Type: Drugs Reason for Announcement:

Recall Reason Description

Product may be sub potent

Product Description

Nature-Throid and WP Thyroid

RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid or WP Thyroid, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. has not received any reports of adverse events related to this recall.

Nature-Throid and WP Thyroid (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles.

To best identify the product, the NDCs, Product Descriptions, Lot Numbers and Expiration Dates are listed in the below documents. These lots were distributed nationwide in the USA to RLC Labs, Inc.s direct accounts, including healthcare professionals and retail pharmacies.

RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid and WP Thyroid should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Lot Numbers

09/03/2020

Originally posted here:
RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid and WP Thyroid with Current Expiry Due to Sub Potency - FDA.gov

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