Acella Pharmaceuticals thyroid medication under voluntary recall. ET. The affected products were recalled due to the results from the samples that were tested by the U.S. Food and Drug Administration (FDA). A recall notice on the FDA’s website from Acella Pharmaceuticals states that one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets, USP were found to be “sub potent.” These lots were distributed nationwide in the USA to Acella’s direct accounts. ABOUT ACELLA and NP THYROID: Acella Pharmaceuticals, LLC is a specialty pharmaceutical company. The Food and Drug Administration website provides a list of the lots affected and can be found here. NEW YORK (CBSNewYork) – Acella Pharmaceuticals is voluntarily recalling its NP Thyroid tablets after testing found them to be “superpotent.” The company says the affected products may contain up to 115% of the labeled amount of Liothyronine. The products are being recalled because our testing has found these lots to be superpotent. Patients should talk to their healthcare professional before they stop taking their NP Thyroid® medicine. Find several options for contacting us! The product may have up to 115.0% of the labeled amount of Liothyronine (T3) (FDA). The products are being recalled because our testing has found these lots to be superpotent. May 22, 2020: “Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. These lots were distributed nationwide in the USA to Acella’s direct accounts. On Jun 8, 2020 I received a letter from my pharmacy about a voluntary recall by Acella Pharmaceuticals, LLC on 13 lots of NP Thyroid 30, 60, and 90mg. Acella Pharmaceuticals has issued a recall with the U.S. Food and Drug Administration of three strengths of medication used to treat hypothyroidism (underactive thyroid.). “The products are being recalled because these lots have been found to be super potent by the manufacture. https://www.kold.com/2020/09/21/thyroid-pills-recalled-by-acella-pharmaceuticals The product may have up to 115.0% of the labeled amount of liothyronine (T3). With Elena Christofides MD. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Acella Pharmaceuticals, LLC recalled 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 product may have up to 115.0% of the labeled amount of Liothyronine (T3).” Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. 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. The products subject to recall are packed in 100-count bottles. The FDA announced a recall of thyroid medicine from Acella Pharmaceuticals, LLC . Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency Published: Sep 18, 2020 ATLANTA , Sept. 18, 2020 /PRNewswire/ -- 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. Its desiccated thyroid called NP Thyroid came out around 2010. The … (Source: FDA) By Gray News Staff | September 21, 2020 at 11:47 AM EDT - Updated September 21 at 11:49 AM (Gray News) - The U.S. Food and Drug Administration issued a recall notice for Acella Pharmaceuticals, LLC for two lots of medicine for people with hypothyroidism. Acella Pharmaceuticals’ FDA-posted recall notice says testing determined 13 lots of its NP Thyroid tablets in 30 mg, 60 mg and 90 mg strengths were super potent. Acella Pharmaceuticals – Recall of NP Thyroid ® (thyroid tablets) May 22, 2020 - Acella Pharmaceuticals announced a consumer-level recall of thirteen lots of NP Thyroid (thyroid tablets) because testing has found the recalled lots to be superpotent. See product images. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency, Recent Recalled Product Photos on FDA's Flickr Photostream. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. You can also visit www.npthyroid.com for more information and answers to frequently asked questions. The products are being recalled because our testing has found these lots to be superpotent. (Source: FDA) By Gray News Staff | September 21, 2020 at 10:47 AM CDT - Updated September 21 at 10:49 AM (Gray News) - The U.S. Food and Drug Administration issued a recall notice for Acella Pharmaceuticals, LLC for two lots of medicine for people with hypothyroidism. In addition, Acella failed to pursue a long-term stability study for lots of NP Thyroid produced by its CMO and a new API supplier back in May 2019, the FDA said. In May 2020, Acella Pharmaceuticals recalled 13 lots of NP Thyroid tablets due to super-potency. Download PDF Before sharing sensitive information, make sure you're on a federal government site. Consumers can also call Acella at 1-800-541-4802 or by email at recall@acellapharma.com. 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. See product images. “Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency Provided by PR Newswire Sep 18, 2020 3:05 PM UTC Consumers with questions can email Acella Pharmaceuticals at recall@acellapharma.com or contact 1-888-280-2044 Monday through Friday from 8 a.m. to 5 p.m. To date, Acella has received two reports of adverse events known to be related to this recall. Acella Pharmaceuticals Recalls Thyroid Tablets Due to Sub Potency Fourth Estate Wire - Modified date: February 18, 2021 0 Acella Pharmaceuticals, LLC recalled one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP to the consumer level. Patients have often happily … 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. Acella Pharmaceuticals, LLC. This is a quote directly from the letter. The FDA announced a recall of thyroid medicine from Acella Pharmaceuticals, LLC . Acella Pharmaceuticals, LLC. The products are being recalled because testing has found these lots to be sub potent. Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. The products are being recalled because these lots have been found to be super potent by the manufacturer. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. The products are being recalled because our testing has found these lots to be superpotent. Its desiccated thyroid called NP Thyroid came out around 2010. Acella Pharmaceuticals is reporting the recall to its wholesale distributors in order to stop distributing the medications. Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Our diverse portfolio of therapeutic products helps patients with a variety of healthcare needs. The product may have up to 115.0% of the labeled amount of liothyronine (T3). Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The voluntary recall of NP Thyroid by Acella Pharmaceuticals, LLC. One lot of 15-mg and one lot of 120-mg NP Thyroid tablets, USP were voluntarily recalled by … The products subject to recall are packed in 100-count bottles. The products are being recalled because our testing has found these lots to be superpotent. Visit GoodRx to find the lowest product pricing in your area. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Earlier this month, another manufacturer called RLC Labs recalled 483 lots of two thyroid medications called WP Thyroid and Nature-Thyroid for sub-potency. Acella Pharmaceuticals, LLC is a specialty pharmaceutical company committed to innovating the healthcare field by bringing quality and affordable products to our customers and patients. NP Thyroid® (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products are being recalled because our testing has found these lots to be superpotent. Written by Kathleen Doheny | Reviewed by Jessica Rodriguez CNP. Withdrawals, & Do you have any questions or comments about our products, company or website? Acella had received four reports of adverse events for these lot numbers possibly related to this recall. The products subject to recall … This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Acella Pharmaceuticals is recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets [levothyroxine (T4) and liothyronine (T3)]. For legal information regarding our products, please view our Product Disclaimer. Acella Pharmaceuticals’ NP Thyroid drug is distributed throughout the United States and comes in 30 mg, 60 mg, and 90 mg tablets. ABOUT ACELLA and NP THYROID: Acella Pharmaceuticals, LLC is a specialty pharmaceutical company. Pregnant women who take superpotent NP Thyroid® may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. This past week, Acella Pharmaceuticals voluntarily recalled a total of 13 lots of 30-mg, 60-mg, and 90-mg NP thyroid tablets, citing issues that the medication is ''super potent." The FDA recommends that patients currently taking NP Thyroid should not discontinue taking the medications without talking to their prescribing physician for guidance and a new prescription. The Acella Pharmaceuticals recall is the most recent, but it's far from the only one. Acella Pharmaceuticals: NP Thyroid Medication Recall Acella voluntarily recalls thyroid supplement, saying it may have up to 115% of the labeled amount of liothyronine . 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. May 21, 2020 Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid ® (thyroid tablets, USP) to the consumer level. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). 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. 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. Acella Pharmaceuticals recalled one lot of 15 mg and one lot of 120 mg NP Thyroid brand tablets. Adverse reactions or quality problems experienced with its use may be reported to the FDA’s MedWatch Adverse Event Reporting program. Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. Acella Pharmaceuticals – Recall of NP Thyroid ® (thyroid tablets) May 22, 2020 - Acella Pharmaceuticals announced a consumer-level recall of thirteen lots of NP Thyroid (thyroid tablets) because testing has found the recalled lots to be superpotent. Some lots of these NP Thyroid tablets have been recalled by Acella Pharmaceuticals. The recalled tablets come in 100-count bottles, and they have an expiration date of July, August, November, or December of 2020. So far, Acella says it has received four reports of "adverse events" for these lot numbers, possibly related to the recall. (Gray News) - The U.S. Food and Drug Administration issued a recall notice for Acella Pharmaceuticals, LLC for two lots of medicine for people with hypothyroidism. Acella Pharmaceuticals’ FDA-posted recall notice says testing determined 13 lots of its NP Thyroid tablets in 30 mg, 60 mg and 90 mg strengths were super potent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. is voluntarily recalling a total of 13 lots of 30mg, 60mg, and 90mg NP Thyroid® to the patient level. •Postherpetic Neuralgia ( 2.1) •Dose can be titrated up as needed to a dose of 1800 mg/day •Day 1: Single 300 mg dose •Day 2: 600 mg/day (i.e., 300 mg two times a day) •Day 3: 900 mg/day (i.e., 300 mg three times a day) () •Epilepsy with Partial Onset Seizures ( 2.2) •Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg … The .gov means it’s official.Federal government websites often end in .gov or .mil. https://www.knoe.com/2020/09/21/thyroid-pills-recalled-by-acella-pharmaceuticals (Gray News) - The U.S. Food and Drug Administration issued a recall notice for Acella Pharmaceuticals, LLC for two lots of medicine for people with hypothyroidism. 1111 E Herndon Ave #204, Fresno, CA 93720 © 2021 JKA Attorneys Website Maintained by BCT Consulting FDA does not endorse either the product or the company. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. One lot of 15-mg and … To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. Safety Alerts, An official website of the United States government, : Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. The voluntary recall of NP Thyroid by Acella Pharmaceuticals, LLC. PRIVACY POLICY | TERMS & CONDITIONS ©2020 ACELLA PHARMACEUTICALS, LLC. More Recalls, Market Photo credits: Acella pharmaceuticals. Alpharetta-based Acella Pharmaceuticals is voluntarily recalling 13 lots of a thyroid medication after receiving two reports that patients who … The site is secure. 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. Acella Pharmaceuticals is recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets [levothyroxine (T4) and liothyronine (T3)]. Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency Sep 17, 2020 | Audience: Consumer, Health Professional, Pharmacy. Adverse events 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. Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid®, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances.
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