Thyroid desiccated FDA Alerts

Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

April 30, 2021 -- Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP 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. To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.

NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below.

To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed on Attachment A hereto. These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.

Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. 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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Attachment A

Table 1. List of 35 Recalled Commercial Lots (100-count Bottles)

Table 2. List of 3 Recalled Sample Lots (7-count Bottles)

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

September 17, 2020 -- Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at npthyroid.com/product-updates.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP 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. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall.

NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.

To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.

See Product Labels:

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-280-2044 Monday through Friday from 8:00 am to 5:00 pm ET. 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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Source: FDA

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

September 3, 2020 -- 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 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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

• Lot Numbers

Source: FDA

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Announcement: Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

Levothyroxine and Liothyronine (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. Thyroid tablets contain both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated as replacement or supplemental therapy in patients with hypothyroidism. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. Thyroid is not associated with serious adverse reactions and does not have a known tumorigenic potential.

Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.

The products subject to recall are packed in 100-count bottles. To best identify the product the NDC’s, Product Description, Lot numbers and Expiration dates are listed below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.

Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their sub-wholesale accounts of this product recall and make arrangements for impacted product to be returned to Westminster. Instructions for returning recalled products are given in the Recall Notice Letter and Recall Response Form. Consumers that have these products which are being recalled should not discontinue use before contacting their physician for further guidance.

Customers and patients with medical-related questions, information about an adverse event or other questions about the Westminster’s product’s being recalled should contact Westminster’s Regulatory Affairs department by phone at: 888-354-9939

• Live calls are received Monday-Friday, 9:00AM - 5:00PM EST with voicemail available 24 hours/day, 7 days/week or email recalls@wprx.com.

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.

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178