"In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.". M327E19-1, expiration date October 2020. Our list of Recalls includes automotive, appliance, food, technology, clothing, and more. "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. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. Newborn infants may develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments. This is the second recall this month related to deficiencies in the active ingredients in drugs used to treat hypothyroidism. The product may have as low as 87% of the labeled amount of levothyroxine.". Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of … The Acella Pharmaceuticals recall is the most recent, but it's far from the only one. ET. October 15, 2020 Kimberly-Clark Announces Recall of Cottonelle Flushable Wipes Sold at: Walmart stores, Walmart.com, Sam's Clubs and SamsClub.com. 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. Patients who are currently taking levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP from the lots being recalled should not abruptly stop the medication. In June, the Food and Drug Administration (FDA) ruled that several generic levothyroxine preparations had the same clinical effect and … I can’t find it at the moment, but the Acella website stated this recall was about NP made in late 2018. Audience: Consumer, Health Professional, Pharmacy. THE RECALL: The first official FDA-announced recall was announced May, 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. Patients should contact their healthcare provider for further guidance and/or a replacement prescription. The products are being recalled because testing of samples from six lots by the FDA found the samples to be sub-potent. Lots of popular thyroid hormone replacement medication, levothyroxine / liothyronine, were recently recalled due to concerns over contamination. The product may have as low as 87% of the labeled amount of levothyroxine (T4). Medications with “use by,” “discard after” or “expiration date” on or after December 2020 are not impacted by the recall. A synthetic Levothyroxine recall in January 2020 in the UK is similar in nature and degree. 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. All rights reserved. ... LLC, is recalling Levothyroxine and Liothyronine tablets in 15 mcg, 30 mcg, ... Crock-Pot burns spark recall of nearly 1M units. Symptoms of hypothyroidism can return in patients treated for an underactive thyroid who take a subpotent drug, the FDA warned. Facebook Share 7 months ago. (CBS) — There is a recall out for certain thyroid medications because they may not be strong enough to be effective. 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. the Food and Drug Administration announced last week. 42192-328-01, Lot No. 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). 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. Next, we should put this recall in context of other drug recalls. 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. This blog post is meant to keep you up to date with all three of the major … We will … M328F19-3, expiration date November 2020. 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. 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. Lot numbers are: NP Thyroid 30 mg: Lot M329A19-1 expiration 20-Dec, lot … Another pharmaceutical company has recalled its medication for an underactive thyroid because it may not be strong enough. Date – November 2020). The FDA said Acella is proactively notifying its wholesalers to discontinue distribution of the recalled products. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. Patients who received sub potent levothyroxine (t4) and liothyronine (t3) thyroid tablets, USP may experience signs and symptoms of hypothyroidism (underactive thyroid). If a recall does relate to the ... CLASS I. The recall affects 37 unexpired lots of levothyroxine and liothyronine (Thyroid Tablets, USP) 15, 30, 60, 90 and 120 milligrams. 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. 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. Sep 17, 2020. 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 Levothyroxine is one of two active ingredients in the drugs used to treat hypothyroidism, or an underactive thyroid. Acella has received four reports of "adverse events” for the medication. 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. Latest News 2020 has been a rough year for everyone but especially for thyroid patients! The affected lots include one NP Thyroid® 15 mg (Lot #M327E19-1; Exp. Full Story. 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. Here’s what you need to know about the recall. Earlier this month, another manufacturer called RLC Labs recalled 483 lots of two thyroid medications called WP Thyroid and Nature-Thyroid for sub-potency. 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. Then John will discuss the financial results in more detail, including the company's fiscal 2020 financial guidance. 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.. The recall affects 13 lots of 30-mg, 60-mg, and 90-mg tablets, which came in 100-count bottles. 42192-328-01, Lot No. I have called Wockhardt in Wrexham for an update and they cannot give me a ETA. M328F19-3, expiration date November 2020. This is interesting as I normally have 50mcg oral solution Levothyroxine and I cannot get it as it’s out of stock. The company is … However, we incorrectly included an image of another Risk in pregnant women include early miscarriage. Date – October 2020) and one NP Thyroid® 120 mg (Lot #M328F19-1; Exp. It referred to super potency for the 30mg, 60mg and 90mg tablets. There is reasonable risk of serious injury in special populations with hypothyroidism. RLC Labs recalled 483 lots of Nature-Throid and WP Thyroid, NP Thyroid 15, Thyroid Tablets, USP, ¼ grain (15 mg), NDC No. Manufactured by: RLCLabs or Packaged by: PD-Rx Pharmaceuticals Incorporated. The other active ingredient is liothyronine. This story was reported from Cincinnati. 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. Acella Pharmaceuticals is voluntarily recalling one … 42192-327-01, Lot No. 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. 2020 Has Been a Rough Year For Thyroid Patients. ", 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. The recalled 120 mg tablet has lot number M328F19-3, an expiration date of November 2020 and NDC number of 42192-328-01. The pills subject to recall are packed in 100-count bottles. The drug is used to improve symptoms of hypothyroidism like slow speech, lack of energy, weight gain, hair loss and dry skin. ET to 5 p.m. Medications with “use by,” “discard after” or “expiration date” on or after December 2020 are not impacted by the recall. NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg); NDC 42192-327-01; lot no. Elderly patients may experience cardiac pain, palpitations, or cardiac arrhythmia. 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. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In May 2020, Acella Pharmaceuticals recalled 13 lots of NP Thyroid tablets due to super-potency. 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. M327E19-1; expiration date Oct. 2020. Find Recalls from December 2020 on ConsumerAffairs. Click here to read the FDA’s full recall … So I requested 100mcg oral solution and I had the same reply also out of … In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Acella Pharmaceuticals announced the voluntary recall of 1 lot of NP ... as low as 87% of the labeled amount of levothyroxine. These 13 people defined the Bay Area in 2020. ... on or after December 2020 are not impacted by this recall. 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. All lots with expiry between 10/2020-07/2023 or Lot #: J18C68, exp. Levothyroxine is taken by more than 13 million Americans to treat an underactive thyroid, thyroid gland enlargement, nodules, or cancer. 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