Patients and healthcare providers can report any adverse reaction related to subpotent NP Thyroid® products to the FDA’s MedWatch program in 1 of 2 ways. Levothyroxine is taken by more than 13 million Americans to treat an underactive thyroid, thyroid gland enlargement, nodules, or cancer. This is the second recall this month related to deficiencies in the active ingredients in drugs used to treat hypothyroidism. Acella Pharmaceuticals is recalling two lots of its thyroid medication after testing found they may not be strong enough, the Food and Drug Administration announced last week. This story was reported from Cincinnati. Latest News Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or call 1-888-280-2044 Monday through Friday from 8:00 a.m. The products are being recalled because testing of samples from six lots by the FDA found the samples to be sub-potent. Medications with “use by,” “discard after” or “expiration date” on or after December 2020 are not impacted by the recall. Lot numbers are: NP Thyroid 30 mg: Lot M329A19-1 expiration 20-Dec, lot … All rights reserved. The recalled products were distributed nationwide and packed in 100-count bottles: According to the announcement, Acella has “received four reports of adverse events” for the medication. The recall affects 13 lots of 30-mg, 60-mg, and 90-mg tablets, which came in 100-count bottles. 42192-327-01, Lot No. Thyroid hormones, including Levothyroxine sodium tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. Sep 17, 2020. The recalled 120 mg tablet has lot number M328F19-3, an expiration date of November 2020 and NDC number of 42192-328-01. The other active ingredient is liothyronine. The company is … Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of … Earlier this month, another manufacturer called RLC Labs recalled 483 lots of two thyroid medications called WP Thyroid and Nature-Thyroid for sub-potency. Another pharmaceutical company has recalled its medication for an underactive thyroid because it may not be strong enough. Our list of Recalls includes automotive, appliance, food, technology, clothing, and more. Patients should contact their healthcare provider for further guidance and/or a replacement prescription. THE RECALL: The first official FDA-announced recall was announced May, 2020. Next, we should put this recall in context of other drug recalls. The product may have as low as 87% of the labeled amount of levothyroxine.". Lots of popular thyroid hormone replacement medication, levothyroxine / liothyronine, were recently recalled due to concerns over contamination. 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 Updated Sep 09, 2020; Posted Sep 09, 2020 RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid because they may be subpotent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). In June, the Food and Drug Administration (FDA) ruled that several generic levothyroxine preparations had the same clinical effect and … October 7, 2020 ", Sportmix Pet Food Recalled After Deaths of at Least 28 Dogs, Ceiling Fans Sold at Home Depot Recalled After Blades Fly Off, Copyright © 2021 NBCUniversal Media, LLC. (CBS) — There is a recall out for certain thyroid medications because they may not be strong enough to be effective. If a recall does relate to the ... CLASS I. This blog post is meant to keep you up to date with all three of the major … The recall affects 37 unexpired lots of levothyroxine and liothyronine (Thyroid Tablets, USP) 15, 30, 60, 90 and 120 milligrams. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. ET to 5 p.m. Risk in pregnant women include early miscarriage. M327E19-1; expiration date Oct. 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 Food and Drug Administration announced last week. M327E19-1, expiration date October 2020. The recall comes after the Florida-based Westminster Pharmaceuticals used ingredients that were found to have deficiencies in conjunction with the FDA’s current good manufacturing practices. 42192-328-01, Lot No. In May 2020, Acella Pharmaceuticals recalled 13 lots of NP Thyroid tablets due to super-potency. Levothyroxine is one of two active ingredients in the drugs used to treat hypothyroidism, or an underactive thyroid. The drug is used to improve symptoms of hypothyroidism like slow speech, lack of energy, weight gain, hair loss and dry skin. It referred to super potency for the 30mg, 60mg and 90mg tablets. Acella has received four reports of "adverse events” for the medication. I have called Wockhardt in Wrexham for an update and they cannot give me a ETA. A synthetic Levothyroxine recall in January 2020 in the UK is similar in nature and degree. "In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.". I can’t find it at the moment, but the Acella website stated this recall was about NP made in late 2018. All lots with expiry between 10/2020-07/2023 or Lot #: J18C68, exp. M328F19-3, expiration date November 2020. Patients who received sub potent levothyroxine (t4) and liothyronine (t3) thyroid tablets, USP may experience signs and symptoms of hypothyroidism (underactive thyroid). 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. Date – November 2020). Additional information is available at the following links: 50 N Medical Dr A050Salt Lake City, Utah 84132, Complete a paper form and fax to 1-800-FDA-0178. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Newborn infants may develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments. Audience: Consumer, Health Professional, Pharmacy. Date – October 2020) and one NP Thyroid® 120 mg (Lot #M328F19-1; Exp. ... on or after December 2020 are not impacted by this recall. October 21, 2020 Jakks Pacific Recalls to Repair Morfboard® Skate & Scoot Scooters Due to Fall Hazard Sold at: Walmart stores and Walmart.com. Symptoms of hypothyroidism can return in patients treated for an underactive thyroid who take a subpotent drug, the FDA warned. Elderly patients may experience cardiac pain, palpitations, or cardiac arrhythmia. Click here to read the FDA’s full recall … On August 15 and 16, 2018, WRCB TV reported on a recall of a levothyroxine and liothyronine product manufactured by Westminster Pharmaceuticals. October 15, 2020 Kimberly-Clark Announces Recall of Cottonelle Flushable Wipes Sold at: Walmart stores, Walmart.com, Sam's Clubs and SamsClub.com. The pills subject to recall are packed in 100-count bottles. These 13 people defined the Bay Area in 2020. Patients who are currently taking levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP from the lots being recalled should not abruptly stop the medication. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Facebook Share Acella LLC is recalling specific lots of 15 mg and 120 mg levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP (NP Thyroid) due to sub potency identified during testing. ... LLC, is recalling Levothyroxine and Liothyronine tablets in 15 mcg, 30 mcg, ... Crock-Pot burns spark recall of nearly 1M units. These kinds of quality control issues happen now and then to all drug categories, and thyroid pharmaceuticals of all types, not just desiccated thyroid, face them. NP Thyroid Recall by Acella. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Medications with “use by,” “discard after” or “expiration date” on or after December 2020 are not impacted by the recall. RLC Labs recalled 483 lots of Nature-Throid and WP Thyroid, NP Thyroid 15, Thyroid Tablets, USP, ¼ grain (15 mg), NDC No. This is interesting as I normally have 50mcg oral solution Levothyroxine and I cannot get it as it’s out of stock. We've had to deal with several recalls of thyroid medications over the year which has caused a significant amount of stress for those who suddenly had to switch medications or dosages.. "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," according to the announcement. ET. NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg); NDC 42192-327-01; lot no. We will … So I requested 100mcg oral solution and I had the same reply also out of … 2020 Has Been a Rough Year For Thyroid Patients. Thyroid news report: On May 22nd, 2020 Acella Pharmaceuticals issued a voluntary nationwide recall of certain lots of NP thyroid due to superpotency.. Don't worry, I'm going to explain in plain English what this all means and how it applies to you. 42192-328-01, Lot No. 7 months ago. The Acella Pharmaceuticals recall is the most recent, but it's far from the only one. Then John will discuss the financial results in more detail, including the company's fiscal 2020 financial guidance. The company is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets “because testing found these lots to be sub potent. The affected lots include one NP Thyroid® 15 mg (Lot #M327E19-1; Exp. Earlier this month, RLC Labs recalled 483 lots of Nature-Throid and WP Thyroid because tests revealed they "may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4). Acella Pharmaceuticals is voluntarily recalling one … Manufactured by: RLCLabs or Packaged by: PD-Rx Pharmaceuticals Incorporated. Full Story. Acella Pharmaceuticals announced the voluntary recall of 1 lot of NP ... as low as 87% of the labeled amount of levothyroxine. One of the most popular drugs in the country, levothyroxine also known as the brand name Synthroid is in short supply, making prices higher and even leaving some patients without the drug. There is reasonable risk of serious injury in special populations with hypothyroidism. Symptoms can 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," the agency said. 2020 has been a rough year for everyone but especially for thyroid patients! Here’s what you need to know about the recall. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. Signs and symptoms of hypothyroidism include constipation, puffy face, slow heart rate, hair loss, increased sensitivity to cold, fatigue, dry skin, swelling of the thyroid gland, depression and/or difficulty losing weight or unexplained weight gain. Levothyroxine (T4)/Liothyronine (T3) (NP Thyroid) Tablet Recall Sep 21, 2020 1:00 PM Acella LLC is recalling specific lots of 15 mg and 120 mg levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP (NP Thyroid) due to sub potency identified during testing. Find Recalls from December 2020 on ConsumerAffairs. M328F19-3, expiration date November 2020. However, we incorrectly included an image of another The FDA said Acella is proactively notifying its wholesalers to discontinue distribution of the recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider first for further guidance and/or a replacement prescription. The shortage is a result of hurricanes Irma and Maria, which hit Puerto Rico nearly four months ago, and knocked out manufacturing facilities for many drugs and medical supplies, including levothyroxine.