OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. But bringing on a production partner can pose quality risks—a reality Georgia-based Acella Pharmaceuticals is finding out the hard way. 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. inbox. “The products are being recalled because these lots have been found to … The voluntary recall of NP Thyroid by Acella Pharmaceuticals, LLC. 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. The Judge overseeing this case is Judge Harry Lee Hudspeth. Case Summary. You may update or cancel your subscription at any time. Lawsuit: Thyroid medicine unpredictable. (FDA), Innovation in Rare Disease: Making Progress with Cell & Gene Therapies – A Webinar Series from the Rare Disease Innovations Institute and Syneos Health®. 6 hours ago, By Savannah Howe | 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. Friday, February 19 th from 10 a.m. – 6 p.m. EST. OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. Acella agreed the same month to voluntarily recall those lots and acknowledged two side-effects reports. All rights reserved. The suit follows a Sept. 17 recall of lots of its NP Thyroid tablets found to be subpotent. 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. Plaintiff … If you are seeking pharma sales jobs, you’re invited to Best Place to Work winner Acella and Avion Pharmaceuticals virtual career fair. 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. Enclose phrases in quotes. All rights reserved. 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. Join us for the Acella Virtual Career Fair. On May 22nd, 2020 Acella Pharmaceuticals issued a voluntary nationwide recall of certain lots of NP thyroid due to superpotency. 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. Our diverse portfolio of therapeutic products helps patients with a variety of healthcare needs. © 2021 Legal Newsline. Thyroid drugs made with ingredient from banned Chinese plant recalled in U.S. 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. (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 … West Virginia Record, By Chris Dickerson | Acella Pharmaceuticals is recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets [levothyroxine (T4) and liothyronine (T3)]. © 2021 Questex LLC. 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. As the pharmaceutical supply chain has grown more geographically diverse, drugmakers have leaned more and more on contract manufacturers to help carry the load. these organizations. Patients with this condition have a thyroid that can’t make enough thyroid hormone. 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. Will be used in accordance with our terms of service & privacy policy. 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. Feb 18, 2021, By John O'Brien | Don't worry, I'm going to explain in plain English what this all means and how it applies to you. Thyroid Medication Recalled Due to Incorrect Dosage. 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. We will email you whenever we publish an article about Thyroid Tablets, USP. Acella PHARMACEUTICALS, LLC Acella Pharmaceuticals, LLC v. Bi-Coastal Pharma International, LLC, Court Case No. The products are being recalled because our testing has found these lots to be superpotent. The Newsletter Bringing the Legal System to Light. Reproduction in whole or part is prohibited. Sign-up Date: NDC 42192-330-01. Subscribe to FiercePharma to get industry news and updates delivered to your inbox. The FDA found that Acella failed to create adequate assays for its thyroid med NP Thyroid. Use a + to require a term in results and - to 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.” Feb 19, 2021, By Daniel Fisher | 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 … 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 testing has found these lots to be sub potent. You may edit your settings or unsubscribe at any time. Everett's lawsuits seek to immediately and permanently prevent Acella from making, selling, and distributing in the United States its infringing, copycat products. They claim Acella is selling some thyroid tablets that contain less Levothyroxine and Liothyronine than advertised. 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. Prescription Drug Lawsuits: List of Medications For Pharmaceutical Lawsuits. 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. The generic name for … 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. 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. (Grivner, Geoffrey) [Transferred from Delaware on 1/22/2019.] Sign-up and get latest news about the courts, judges and latest complaints - right to your This is the ACELLA PHARMACEUTICALS company profile. any of these organizations, 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. Next time we write about NP Thyroid 60. 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. Feb 19, 2021, By Savannah Howe | This can lead to serious issues as the body struggles to function without an essential hormone. OCALA, Fla. (Legal Newsline) – Thyroid medicine sold by Acella Pharmaceuticals is either too strong or too weak, a class action lawsuit says. Feb 18, 2021, By John O'Brien | Scientist studying PFAS for courts says no. 1 grain (60 mg) Rx Only 100 Tablets. FDA knocks Acella for lax controls on thyroid medicine recalled in May. Learn more about the exciting and lucrative career of a Pharmaceutical Sales Rep with Acella and Avion Pharmaceuticals. 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. 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. August 30, 2017: Summons Reissued with Magistrate Consent Notice attached as to Method Pharmaceuticals, LLC, Matthew Scott Tucker. About Acella Pharmaceuticals, LLC Acella develops markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in … Location of This Business 11675 Great Oaks Way Ste 144, Alpharetta, GA 30022-2402 Email this Business COVID liability immunity bill passes state Senate, heads to House of Delegates, Executive says she was fired over condition that causes daytime sleepiness, Police Athletic League facing lawsuit for alleged 1970s sexual abuse, Lawsuit: NYC priest raped young girl the night of her dad's funeral, Insurers make plea to judge that some sex abuse claims against Boy Scouts could be fake, Court says McDonald's can sue ex-CEO over sex allegations, Lawsuit says toddler lost part of finger thanks to door at Massachusetts day care, Death of homeless man in NYC shelter leads to lawsuit, Nestle hit with vanilla lawsuit over Coffee Mate, Bloomberg wouldn't be vicariously liable for sexual abuse at his company, court rules, Eighth Circuit predicts Nebraska law in case over medical device warnings, Gerber, Hain face class action over heavy metals in baby food, Lawyers get $1.1M for five years of work suing Santa Barbara over jail conditions, Lawyers get sued for losing woman's discrimination lawsuit, Maine signature-gathering law violates free speech, judge rules; Appeal welcomed, Hospital to face lawsuit over newborn suffocating under mom's breast, Washington county's lax supervision of criminal who beat estranged wife gets it in trouble, Hearing tomorrow about possibly fraudulent sexual abuse claims against Boy Scouts, Calif. court lets mom keep pushing wrongful death suit over bicycle accident, Is enough known about 'the ultimate mass tort?' 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) … Thank you for signing up for Legal Newsline Alerts! Testing has showed some tablets, which are used to treat underactive thyroids, contain more of the active ingredient than advertised, the suit says. ACELLA PHARMACEUTICALS Sales Salaries 6 salaries (for 5 job titles) Updated Oct 18, 2017 6 ACELLA PHARMACEUTICALS employees have shared their salaries on Glassdoor. you wish to subscribe to. Feb 17, 2021. Lot #/Exp. 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: All content is posted anonymously by employees working at ACELLA PHARMACEUTICALS. NP Thyroid is manufactured by Acella Pharmaceuticals as a treatment of hypothyroidism. 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. we'll email you a link to the story. August 9, 2017 Westminster said at the time it used the Chinese API to make its thyroid drug before the FDA had put the ban in place. This is a quote directly from the letter. 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. 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 product may have up to 115.0% of the labeled amount of Liothyronine (T3) (FDA). Bursor & Fisher, P.A • Acella Pharmaceuticals, LLC, From Plaintiff Cara Truax and her lawyers at Bursor & Fisher filed suit Oct. 13 in Florida federal court in Ocala. 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. Method Pharmaceuticals, LLC served on 8/30/2017, answer due 9/20/2017. Please Protected by Google ReCAPTCHA. 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. exclude terms. “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. Glassdoor gives you an inside look at what it's like to work at ACELLA PHARMACEUTICALS, including salaries, reviews, office photos, and more. select the organizations MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 . 1:15-cv-02847 in the Georgia Northern District Court. 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. (crb) [Transferred from Delaware on 1/22/2019.] By signing up for alerts, you agree to the privacy policy & terms of service.