Thyroid Product Recalled for Sub Potency

Summary
Company Announcement Date:
September 03, 2020
FDA Publish Date:
September 03, 2020
Product Type:
Drugs
Reason for Announcement:
Product may be sub potent
Company Name:
RLC Labs, Inc
Brand Name:
RLC Labs
Product Description:
Nature-Throid® and WP Thyroid®
Company Announcement
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 NDC’s, 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 [email protected] 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.

Read the full FDA report here.
As published by HealthyExaminer.com

Hand Sanitizer Recalled for Wood Alcohol and Subpotent Ethanol Levels

Summary
Company Announcement Date:
September 09, 2020
FDA Publish Date:
September 10, 2020
Product Type:
Drugs
Reason for Announcement:
Contains Methanol and may be Sub-Potent for Ethanol
Company Name:
Medek, LLC
Brand Name:
M
Product Description:
M Hand Sanitizer Alcohol Antiseptic 80%
Company Announcement
Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections. To date, Medek, LLC. has not received any reports of adverse.

The recalled product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The recalled Hand Sanitizer is packaged in a one (1) gallon (128 oz/3,785 mL) High-density polyethylene (HDPE) plastic bottle, NDC 75432-001-02.

The recalled Hand Sanitizer was distributed directly to walk-in customers in Alamo, TX, between the dates of 04/17/2020 to 05/22/2020.

Medek, LLC is notifying its customers/distributors by recall letter and consumers via this press release. We are also notifying our distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled Hand Sanitizer. Consumers, distributors, and retailers that have recalled products should stop use or distribution and return to place of purchase.

Consumers with questions regarding this recall can contact Medek, LLC at (956) 800-4366 (Monday to Friday from 9 am to 5 pm CST). Consumers should contact their physician or healthcare provider if they experience any problem that may be related to the use of this product.

Read the full FDA report here.
As published by HealthyExaminer.com

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