Join patients and their families, legislators, industry experts, advocates and sponsors to discuss education initiatives, recent advancements and the future promise of cell and gene medicine, and current patient experiences with these therapies. We will email you whenever we publish an article about COMPANY ANNOUNCEMENT – Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall COMPANY ANNOUNCEMENT – Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall 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. Patients with this condition have a thyroid that can’t make enough thyroid hormone. (crb) [Transferred from Delaware on 1/22/2019.] The Newsletter Bringing the Legal System to Light. (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 … Date: NDC 42192-330-01. RELATED: Thyroid drugs made with ingredient from banned Chinese plant recalled in U.S. Levothyroxine and liothyronine have been on the FDA's radar in the past as part of a ban on a Chinese API supplier. “Had Plaintiff and class members been aware of the superpotency or subpotency issues, they would not have purchased the Thyroid Tablets, or would have paid significantly less for them,” the suit says. inbox. Join us for the Acella Virtual Career Fair. By signing up for alerts, you agree to the privacy policy & terms of service. Almost a year after manufacturing, validation batches of the drug had still not been studied for long-term potency, casting doubts on its shelf life, the FDA said. Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) … All rights reserved. Consumers with questions can email Acella Pharmaceuticals at recall@acellapharma.com or contact 1-888-280-2044 Monday ... Wisconsin high court declines to hear Trump election lawsuit. NP Thyroid is manufactured by Acella Pharmaceuticals as a treatment of hypothyroidism. 6 hours ago, By Savannah Howe | Lawsuit: Thyroid medicine unpredictable. The FDA found that Acella failed to create adequate assays for its thyroid med NP Thyroid. Feb 18, 2021, By John O'Brien | OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. Location of This Business 11675 Great Oaks Way Ste 144, Alpharetta, GA 30022-2402 Email this Business exclude terms. Acella agreed the same month to voluntarily recall those lots and acknowledged two side-effects reports. © 2021 Questex LLC. select the organizations You may update or cancel your subscription at any time. Will be used in accordance with our terms of service & privacy policy. 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. Learn more about the exciting and lucrative career of a Pharmaceutical Sales Rep with Acella and Avion Pharmaceuticals. Sign-up and get latest news about the courts, judges and latest complaints - right to your Background: On May 22, 2020, Acella Pharmaceuticals voluntarily recalled 13 lots of 30 mg, 60 mg and 90 mg NP Thyroid (thyroid tablets, USP), packaged in 100-count bottles, because testing found these lots to be super potent—i.e., contain up to 115% of the labeled amount of liothyronine (T3).NP Thyroid contains levothyroxine and liothyronine, which treat hypothyroidism (underactive … Thyroid Medication Recalled Due to Incorrect Dosage. Reproduction in whole or part is prohibited. The voluntary recall of NP Thyroid by Acella Pharmaceuticals, LLC. Feb 17, 2021. The generic name for … On May 22nd, 2020 Acella Pharmaceuticals issued a voluntary nationwide recall of certain lots of NP thyroid due to superpotency. Acella PHARMACEUTICALS, LLC On 09/02/2014 Mission Pharmacal Company filed an Intellectual Property - Patent lawsuit against Acella Pharmaceuticals, L L C.This case was filed in U.S. District Courts, Texas Western District. They claim Acella is selling some thyroid tablets that contain less Levothyroxine and Liothyronine than advertised. 1 grain (60 mg) Rx Only 100 Tablets. 1:15-cv-02847 in the Georgia Northern District Court. The products are being recalled because our testing has found these lots to be superpotent. 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. 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(FDA), Innovation in Rare Disease: Making Progress with Cell & Gene Therapies – A Webinar Series from the Rare Disease Innovations Institute and Syneos Health®. Protected by Google ReCAPTCHA. The product may have up to 115.0% of the labeled amount of Liothyronine (T3) (FDA). 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. Westminster said at the time it used the Chinese API to make its thyroid drug before the FDA had put the ban in place. About Acella Pharmaceuticals, LLC Acella develops markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in … NORTH AMERICA – June 1, 2020 – According to an online news report provided by the news website AJC.com, Acella Pharmaceuticals is recalling several lots of their thyroid drug due to severe adverse effects. 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. September 3, 2020 Ohio Legal Updates, Ohio Products Liability As we reported in previous posts here and here, in May 2020 Acella Pharmaceuticals recalled 13 lots of NP Thyroid after finding the product was superpotent and posed significant risks to consumers. © 2021 Legal Newsline. NP Thyroid 60. All content is posted anonymously by employees working at ACELLA PHARMACEUTICALS. Plaintiff Cara Truax and her lawyers at Bursor & Fisher filed suit Oct. 13 in Florida federal court in Ocala. these organizations. Everett's lawsuits seek to immediately and permanently prevent Acella from making, selling, and distributing in the United States its infringing, copycat products. Use a + to require a term in results and - to Sign-up 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.” During an investigation between December and January, FDA investigators found Acella failed to use appropriate assays for the contract-manufactured active pharmaceutical ingredients (API) used in its thyroid drug: levothyroxine and liothyronine. Friday, February 19 th from 10 a.m. – 6 p.m. EST. You may edit your settings or unsubscribe at any time. 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. 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. FDA knocks Acella for lax controls on thyroid medicine recalled in May. The Judge overseeing this case is Judge Harry Lee Hudspeth. The suit follows a Sept. 17 recall of lots of its NP Thyroid tablets found to be subpotent. 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. Acella Pharmaceuticals, LLC v. Bi-Coastal Pharma International, LLC, Court Case No. This is a quote directly from the letter. Don't worry, I'm going to explain in plain English what this all means and how it applies to you. On May 22, 2020, the U.S. Food and Drug Administration (FDA) posted an announcement on its website indicating that Acella Pharmaceuticals, LLC is recalling 13 lots of NP Thyroid tablets. Feb 19, 2021, By Savannah Howe | Our diverse portfolio of therapeutic products helps patients with a variety of healthcare needs. August 9, 2017 Bursor & Fisher, P.A • Acella Pharmaceuticals, LLC, From WASHINGTON, D.C. — Acella Pharmaceuticals, LLC (Acella), with the consent of the U.S. Food and Drug Administration (FDA) announced it would recall thirteen lots of NP Thyroid ® because one of the two active ingredients is super-potent. Subscribe to FiercePharma to get industry news and updates delivered to your inbox. Thyroid drugs made with ingredient from banned Chinese plant recalled in U.S. The products are being recalled because testing has found these lots to be sub potent. OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. In August 2018, Westminster Pharmaceuticals recalled all lots of its generic thyroid med using levothyroxine and liothyronine in five dose forms because it was made with API from China’s Sichuan Friendly Pharmaceutical. you wish to subscribe to. As the pharmaceutical supply chain has grown more geographically diverse, drugmakers have leaned more and more on contract manufacturers to help carry the load. Method Pharmaceuticals, LLC served on 8/30/2017, answer due 9/20/2017. Glassdoor gives you an inside look at what it's like to work at ACELLA PHARMACEUTICALS, including salaries, reviews, office photos, and more. August 30, 2017: Summons Reissued with Magistrate Consent Notice attached as to Method Pharmaceuticals, LLC, Matthew Scott Tucker. Feb 18, 2021, By John O'Brien | Thank you for signing up for Legal Newsline Alerts! Please Feb 19, 2021, By Daniel Fisher | Acella Pharmaceuticals is recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets [levothyroxine (T4) and liothyronine (T3)]. Thyroid Tablets, USP. The Food and Drug Administration announced Thursday that Acella Pharmaceuticals is voluntarily recalling one lot of 15-milligram and one lot of 120-milligram NP Thyroid®, Thyroid Tablets. ABOUT ACELLA and NP THYROID: Acella Pharmaceuticals, LLC is a specialty pharmaceutical company.Its desiccated thyroid called NP Thyroid came out around 2010. “The products are being recalled because these lots have been found to … The FDA banned all products made by Sichuan Friendly in March of that year after an inspection found big problems at the Chinese company's manufacturing plant. While Acella eventually corrected those errors, a May follow-up FDA investigation at its CMO's facility found that 13 lots of NP Thyroid exceeded the specified strength. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 . Plaintiff … This can lead to serious issues as the body struggles to function without an essential hormone. Next time we write about 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. ACELLA PHARMACEUTICALS Sales Salaries 6 salaries (for 5 job titles) Updated Oct 18, 2017 6 ACELLA PHARMACEUTICALS employees have shared their salaries on Glassdoor. (Grivner, Geoffrey) [Transferred from Delaware on 1/22/2019.] The FDA cited Acella after quality control issues with a contract manufacturer led the drugmaker to pull lots of its prescription NP Thyroid med off shelves back in May, according to a warning letter posted online Tuesday. any of these organizations, Lot #/Exp. If you are seeking pharma sales jobs, you’re invited to Best Place to Work winner Acella and Avion Pharmaceuticals virtual career fair. Prescription Drug Lawsuits: List of Medications For Pharmaceutical Lawsuits. But bringing on a production partner can pose quality risks—a reality Georgia-based Acella Pharmaceuticals is finding out the hard way. The FDA noted that due to the "narrow therapeutic range" of NP Thyroid, out-of-spec dosing could pose serious side effects for patients who take the drug. Our dangerous drug lawsuit lawyers are currently handling cases against pharmaceutical companies for the list of medications in the table below.. Click on the drug name below to learn more information about the side effects of the medication, FDA recalls, prescription class action lawsuits, and settlements: West Virginia Record, By Chris Dickerson | 3 Speen Street, Suite 300, Framingham, MA 01701. OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. 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. Case Summary. we'll email you a link to the story. Scientist studying PFAS for courts says no. Enclose phrases in quotes. All rights reserved. Testing has showed some tablets, which are used to treat underactive thyroids, contain more of the active ingredient than advertised, the suit says. This is the ACELLA PHARMACEUTICALS company profile.
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