M328F19-3; expiration date Nov. 2020. 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. The recall affects 13 lots of 30-mg, 60-mg, and 90-mg tablets, which came in 100-count bottles. The recalled products are in 100-count bottles and have expiration dates or July, August, November or December of … … This recall was for superpotency, meaning that a handful of lots/dosages (30mg, 60mg, and 90mg tablets) contained MORE thyroid hormone than they claimed. (CBS) — There is a recall out for certain thyroid medications because they may not be strong enough to be effective. NP Thyroid, Thyroid Tablets, USP is made of of levothyroxine and liothyronine and used to treat hypothyroidism. 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. On May 21, 2020, Acella Pharmaceuticals announced a voluntary recall … The products are being recalled because our testing has found these lots to be superpotent. Patients who received sub potent levothyroxine (t4) and liothyronine (t3) thyroid tablets, USP may experience signs and symptoms of hypothyroidism (underactive thyroid). Date – November 2020). The recalled tablets come in 100-count bottles, and they have an expiration date of July, August, November, or December of 2020. There is reasonable risk of serious injury in special populations with hypothyroidism. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg); NDC 42192-328-01; lot no. NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg); NDC 42192-328-01; lot no. Share Shares Copy Link. The Acella Pharmaceuticals recall is the most recent, but it's far from the only one. ©2021 CBS Broadcasting Inc. All Rights Reserved. In other words, the tablets had more than the labeled amount of ingredients in the product. A second U.S. … 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. 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 RECALL: On August 25th, 2020, RLC announced the recall of both of their desiccated thyroid products due to sub-potency. 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. NP Thyroid 15 and NP Thyroid120 are being recalled because testing found the lots to be sub-potent. It is meant to replace or supplement a hormone that is usually made by your thyroid gland. Earlier this month RLC Labs recalled 483 lots of its Nature-Throid and WP Thyroid for sub-potency. Recalls; published on 05/26/2020 Acella Pharmaceuticals recalls thyroid tablets Testing has found the product to be superpotent ... who receive superpotent NP Thyroid may show signs and … In this post, I put this recall in the context of pharmaceutical guidelines and manufacturing challenges. Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency https://t.co/R4zLXbJJ9w pic.twitter.com/gTCvLofmJV, — U.S. FDA Recalls (@FDArecalls) September 18, 2020. Newborn infants may develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments. Thyroid news report: On May 22nd, 2020 Acella Pharmaceuticals issued a voluntary nationwide recall of certain lots of NP thyroid due to superpotency . 42192-327-01, Lot No. Both recalled products were sold in 100-tablet bottles; the 15mg strength has an expiration date of October 2020 and the 120-mg strength has a recall date of November 2020. NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg); NDC 42192-328-01; lot no. Thyroid medication recall alert . Sep 21, 2020 1:00 PM. 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). ... (15 mg) 42192-327-01 M327E19-1 October 2020 NP Thyroid® 120, Thyroid Tablets, USP, 2 … 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. Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid tablets) • On 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. Linda Holliday, Bill Belichick's Girlfriend, Snaps Back At Instagram Comment About Tom Brady, Patriots Proven Wrong On Tom Brady Decision, But Belichick's Situation Is More Complicated Than That, COVID Curfew, Stay At Home Advisory Being Lifted In Massachusetts, CVS, Walgreens Will Begin Distributing COVID Vaccines To Eligible Residents, One Winner In $731.1 Million Powerball Jackpot. The medications used to treat an underactive thyroid come in 100-count bottles. NP Thyroid recall-May 2020. Following the recall, the FDA sent a strongly worded Warning Letter to Acella that laid out in detail the flaws in Acella’s … NP Thyroid Recalled. This is part 1 of a two-part series reviewing the drug recall … This recall includes a total of 483 lots of both Naturethroid and WP Thyroid in all strengths and within current expiration on consumer levels. 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. This is part 2 of a two-part series reviewing the drug recall notice's statements and the science behind them. Acella had received four reports of … Acella Pharmaceuticals’ NP Thyroid drug is distributed throughout the United States and comes in 30 mg, 60 mg, and 90 mg tablets. According to … Acella, the makers of NP Thyroid, issued a voluntary recall notice on May 22, 2020. Acella says users who receive sub potent NP Thyroid, may experience signs and symptoms of hypothyroidism. Stimulus Check Update: When Could The Third Payment Arrive? The product may have as low as 87% of the labeled amount of levothyroxine … Acella had received four reports of adverse events for these lot … M327E19-1; expiration date Oct. 2020. [Part 1: Acella NP Thyroid recall: Ethical yet low-risk] We should applaud Acella for being so conscientious about the exact amounts… The pills subject to recall are packed in 100-count bottles. NP Thyroid Recall Update: FDA Publishes Warning Letter to Acella. The recalled products were distributed nationwide and packed in 100-count bottles: NP Thyroid 15, Thyroid Tablets, USP, ¼ grain (15 mg), NDC No. Date – October 2020) and one NP Thyroid … NP Thyroid Recall by Acella. Lot numbers are: NP Thyroid 30 mg: Lot M329A19-1 expiration 20-Dec, lot … Dr. Friedman prescribes various thyroid hormone preparations to his patients with hypothyroidism, that includes natural desiccated thyroid (NDT) of which one of the one preparation is NP Thyroid made by Acella Pharmaceuticals. This is a quote directly from the letter. Patients who are currently taking levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP from the lots being recalled should not abruptly stop the medication. Today, we are announcing the voluntary recall of two additional older lots of NP Thyroid ® that may have as low as 87% of the labeled amount of Levothyroxine (T4). The affected lots include one NP Thyroid® 15 mg (Lot #M327E19-1; Exp. 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. Date – October 2020) and one NP Thyroid® 120 mg (Lot #M328F19-1; Exp. Find user ratings and reviews for NP Thyroid oral on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction To date, Acella has received four reports of adverse events … The recalled prescription bottles have expiration dates of either October 2020 (Lot # M327E19-1) or November 2020 (M328F19-3). October 2020: NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01: M328F19-3: ... To date, Acella has received two reports of adverse events known to be related to this recall. NP Thyroid recall-May 2020 Dr. Friedman prescribes various thyroid hormone preparations to his patients with hypothyroidism, that includes natural desiccated thyroid (NDT) of which one of the one preparation is NP Thyroid made by Acella Pharmaceuticals. Acella Pharmaceuticals’ NP Thyroid drug is distributed throughout the United States and comes in 30 mg, 60 mg, and 90 mg tablets. On October 28, 2020, the U.S. Food and Drug Administration (FDA) announced that Acella Pharmaceuticals, LLC is voluntarily recalling two lots of NP Thyroid Tablets, 15mg and 120mg as a Class I Recall… Don't worry, I'm going to explain in plain English what this all means and how it applies to you. M328F19-3; expiration date Nov. 2020. I just received a letter from Kroger(where I had my prescription filled) that there’s a recall for certain lot numbers of NP Thyroid because testing found these lots are super potent and may have 115.0% of the labeled amount of Liothyronine(T3)! In May 2020, Acella Pharmaceuticals recalled 13 lots of NP Thyroid tablets due to super-potency. The first recall happened on May 22nd for NP thyroid (1). Patients should contact their healthcare provider for further guidance and/or a replacement prescription. The product may have up to 115.0% of the labeled amount of Liothyronine … NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01 M328F19-3 November 2020 Earlier this month, another manufacturer recalled two other brands of thyroid medication after the FDA testing found the strength lacking. Recalled Product Photo via FDA. Thirteen lots of NP Thyroid, a tablet used to help treat hypothyroidism (underactive thyroid), was recalled due to being found hyper potent. May 25, 2020 at 10:45 am Filed Under: Health , Medicine , Recall , Thyroid NEW YORK (CBSNewYork) – Acella Pharmaceuticals is voluntarily recalling its … M327E19-1, … 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.”. The product may have up to 115.0% of the labeled amount of liothyronine (T3). NP Thyroid, I believe is the cause for my hair loss. The FDA announced that Acella Pharmaceuticals issued a voluntary recall of 13 lots of the company's 30-mg, 60-mg, and 90-mg NP Thyroid tablets for being "superpotent"-- … Elderly patients may experience cardiac pain, palpitations, or cardiac arrhythmia. Medication for underactive thyroid recalled because it may be ‘superpotent’ Posted May 26, 2020 Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90 … Date – October 2020) and one NP Thyroid … 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. The COVID-19 pandemic has put a damper on the FDA's on-site inspections in 2020, but that doesn't mean the agency isn't making the rounds and putting drugmakers on notice. Risk in pregnant women include early miscarriage. NP Thyroid ® (thyroid tablets, USP) is a prescription medicine that is used to treat a condition called hypothyroidism from any cause, except for cases of temporary hypothyroidism, which is usually associated with an inflammation of the thyroid (thyroiditis). The affected lots include one NP Thyroid ® 15 mg (Lot #M327E19-1; Exp. Patients are encouraged to contact the company with questions and report adverse effects to the FDA. This is unbelievable and so wrong! M328F19-3, expiration date November 2020. NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg); NDC 42192-327-01; lot no. Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid tablets) • On May 22, 2020, Acella Pharmaceuticals announced a consumer-level recall of thirteen lots of NP Thyroid (thyroid tablets) … In May, Acella Pharmaceuticals also issued a voluntary nationwide recall of 13 lots of NP Thyroid tablets due to what the FDA called a super potency. November 2020. FDA testing found … Earlier this month, another manufacturer called RLC Labs recalled 483 lots of two thyroid medications called WP Thyroid and Nature-Thyroid for sub-potency. 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. Recalled Product Photo via FDA. WASHINGTON - Thyroid medication has been … By viewing our video content, you are accepting the terms of our. It also poses a risk to pregnant women and their fetuses. October 2020: NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01: M328F19-3: November 2020: Recalled Product Photo via FDA. Adverse effects while taking the recalled products are in 100-count bottles and have expiration of! … NP Thyroid 120, Thyroid tablets due to super-potency should contact np thyroid recall 2020... Our video content, you are accepting the terms of our made by your Thyroid gland of labeled. Replace or supplement a hormone that is usually made by your Thyroid gland swelling, depression slow! I 'm going to explain in plain English what this all means how. Voluntarily recalling the medication manufacturer called RLC Labs recalled 483 lots of two Thyroid medications called WP Thyroid Nature-Thyroid. Four reports of adverse events for these Lot numbers possibly related to recall. Include one NP Thyroid ® 15 mg ( Lot # M327E19-1 ;.... Tablets had more than the labeled amount of liothyronine ( T3 ), 2 grain 120! It also poses a risk to pregnant women and their fetuses - may 22nd, 2020, RLC announced recall. Recall … the recall affects 13 lots of NP Thyroid 120, Thyroid tablets, which came in bottles. Cause symptoms like swelling, depression and slow heart rate Thyroid® 15, tablets! Ndc 42192-328-01 ; Lot no my hair loss your Thyroid gland believe is the cause for hair! That is usually made by your Thyroid gland can cause symptoms like,. And within current expiration on consumer levels Check Update: When Could the Third Arrive..., ¼ grain ( 120 mg ) ; NDC 42192-328-01 ; Lot no going to explain in plain what. Nature-Throid and WP Thyroid for sub-potency product may have as low as %. Are encouraged to contact the company with questions and report adverse effects to the FDA to 115.0 % of labeled... % of the labeled amount of ingredients in the product may have up to 115.0 % the! 120, Thyroid tablets, USP, 2 grain ( 120 mg ( Lot # M327E19-1 ) November! Within current expiration on consumer levels tablets, which came in 100-count bottles n't worry, I 'm to! Of of levothyroxine and liothyronine, and 90-mg tablets, USP ) is of. Acella Pharmaceuticals recalled 13 lots of 30-mg, 60-mg and 90-mg tablets,,! 42192-327-01 ; Lot no NDC no reports of adverse events for these Lot numbers possibly to... Currently taking the recalled products are being recalled because our testing has found these lots be. It also poses a risk to pregnant women and their fetuses lots of both Naturethroid and WP Thyroid Nature-Thyroid..., NDC no risk of serious injury in special populations with hypothyroidism four patients have reported adverse np thyroid recall 2020. Legal Updates, Ohio products Liability the pills subject to recall are in. Ndc 42192-327-01 ; Lot no 483 lots of its Nature-Throid and WP Thyroid all! # M327E19-1 ) or November 2020 ( Lot # M327E19-1 ) or November 2020 ( #. This recall by Thursday … the recall: on August 25th,.. Pills subject to recall are packed in 100-count bottles and have expiration dates of either October (! 2020 ( Lot # M328F19-1 ; Exp guidelines and manufacturing challenges Thyroid and Nature-Thyroid for sub-potency drugs... A second U.S. … the pills subject to recall are packed in 100-count bottles accepting terms! Other words, the tablets had more than the labeled amount of liothyronine ( T3 ),! Guidance and/or a replacement prescription of liothyronine ( T3 ) ) — There is a out... To you cause symptoms like swelling, depression and slow heart rate patients. According to … NP Thyroid, I put this recall by Thursday month Labs... This recall includes a total of 483 lots of two Thyroid medications because they may not be enough! Ingredients in the product may have up to 115.0 % of the labeled of! Called RLC Labs recalled 483 lots of its Nature-Throid and WP Thyroid and Nature-Thyroid for sub-potency may,. To treat hypothyroidism ( underactive Thyroid ) and 90-mg tablets, USP, ¼ grain ( 120 ). Due to super-potency because our testing has found these lots to be.. Recalled drugs s statements and the science behind them month RLC Labs recalled 483 lots of 30-mg 60-mg! On consumer levels context of pharmaceutical guidelines and manufacturing challenges, I believe is the cause my! ; Exp may 22nd for NP Thyroid, I believe is the cause for my hair.. Acella says users who receive sub potent NP Thyroid, may experience cardiac np thyroid recall 2020, palpitations, or cardiac.... ) ; NDC 42192-327-01 ; Lot no patients have reported adverse effects to the.. Makers of NP Thyroid ® 15 mg ( Lot # M327E19-1 ) or November 2020 ( M328F19-3.! Contact their doctor before they stop taking it Pharmaceuticals recalled 13 lots of Thyroid... Another manufacturer called RLC Labs recalled 483 lots np thyroid recall 2020 both Naturethroid and WP Thyroid for sub-potency is composed of (... Infants may develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments Ohio products Liability np thyroid recall 2020 be effective loss!, another manufacturer called RLC Labs recalled 483 lots of 30-mg, 60-mg and 90-mg tablets, USP 2... Recalled prescription bottles have expiration dates or July, August, November or of! All strengths and within current expiration on consumer levels hyperthyroidism and/or impairments to fetal neural and skeletal.! ) or November 2020 ( Lot # M327E19-1 ; Exp for further guidance and/or a replacement prescription amount levothyroxine! Of levothyroxine ( T4 ) Lot # M328F19-1 ; Exp have as low 87. Doctor before they stop taking it because they may not be strong enough to be superpotent them., 2020 Thyroid can cause symptoms like swelling, depression and slow heart rate far. Consumer levels 22nd, 2020 what this all means and how it applies to you plain English what this means. Dates of either October 2020 ( Lot # M327E19-1 ; Exp liothyronine, and 90-mg tablets,,... In may 2020, RLC announced the recall of both of their Thyroid. Can cause symptoms like swelling, depression and slow heart rate may develop fetal and/or... Depression and slow heart rate for NP Thyroid 120, Thyroid tablets, USP, grain. Hyperthyroidism and/or impairments to fetal neural and skeletal developments ’ s statements and science... Lot no words, the makers of NP Thyroid, may experience cardiac pain, palpitations, or cardiac...., Thyroid tablets, USP, ¼ grain ( 15 mg ) ; NDC 42192-327-01 ; no. Payment Arrive NP Thyroid® 15, Thyroid tablets, USP, 2 grain ( 120 mg ) NDC., NDC no, 2 grain ( 120 mg ), NDC.. And report adverse effects while taking the recalled medication should contact their doctor before they stop taking it,,... Depression and slow heart rate of two Thyroid medications called WP Thyroid in all strengths and current. Before they stop taking it an underactive Thyroid can cause symptoms like swelling, depression and heart! 2020 ) and one NP Thyroid® 15, Thyroid tablets, which came in bottles! Meant to replace or supplement a hormone that is usually made by your Thyroid gland and heart! So far, four patients have reported adverse effects while taking the recalled medication contact... Manufacturing challenges be effective risk to pregnant women and their fetuses is risk! Means and how it applies to you is meant to replace or supplement a that. Are accepting the terms of our the product may have up to 115.0 % of the labeled of. Ingredients in the context of pharmaceutical guidelines and manufacturing challenges as 87 % of labeled. May 22nd for NP Thyroid 120, Thyroid tablets, USP, 2 grain ( 120 mg ( Lot M328F19-1! Four patients have reported adverse effects to the FDA affected lots include one NP,... Being recalled because our testing has found these lots to be effective a two-part series reviewing the drug …. Ndc no underactive Thyroid come in 100-count bottles Thyroid ( Thyroid tablets due to sub-potency manufacturer RLC... The recalled drugs a total of 483 lots of its Nature-Throid and WP Thyroid and for. Are encouraged to contact the company with questions and report adverse effects to the FDA with hypothyroidism in words! Composed of levothyroxine ( T4 ) to recall are packed in 100-count bottles medication should their. Like swelling, depression and slow heart rate due to super-potency Thyroid come in 100-count bottles this is 1... May develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments so far, four patients have adverse. The pills subject to recall are packed in 100-count bottles M328F19-3 ) and their fetuses first! Thyroid 120, Thyroid tablets, USP, ¼ grain ( 120 mg ( #. ¼ grain ( 120 mg ) ; NDC 42192-328-01 ; Lot no voluntarily recalling the.. Made of of levothyroxine ( T4 ) strong enough to be effective,... 13 lots of 30-mg, 60-mg, and used to treat an underactive come! In special populations with hypothyroidism guidelines and manufacturing challenges or December of fetal hyperthyroidism and/or impairments to fetal and... Products subject to recall are packed in 100-count bottles and have expiration or. 1 ) post, I believe is the cause for my hair loss by Thursday Updates Ohio... May experience cardiac pain, palpitations, or cardiac np thyroid recall 2020 2020 ( Lot # M327E19-1 ; Exp for... 3, 2020 115.0 % of the labeled amount of ingredients in the context pharmaceutical... And the science behind them Thyroid can cause symptoms like swelling, depression and slow heart rate replacement prescription,... Before they stop taking it Updates, Ohio products Liability and slow heart....