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Levothyroxine Recall 2020

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Last Updated: 27 November 2020

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General | Latest Info

Another pharmaceutical company has Recall its medication for underactive Thyroid because it may not be strong enough. Acella Pharmaceuticals 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 subpotent. Product may have as low as 87 % of the labeled amount of Levothyroxine, according to an announcement with the US Food and Drug Administration. The medication is composed of Levothyroxine and Liothyronine and is used to treat hypothyroidism, or underactive Thyroid. NP Thyroid 15, Thyroid Tablets, USP, grain, NDC No. 42192-327-01, Lot No. M327E19-1, expiration date October 2020 NP Thyroid 120, Thyroid Tablets, USP, 2 grain, NDC No. 42192-328-01, Lot No. M328F19-3, expiration date November 2020. According to the announcement, Acella has received four reports of adverse events for medication. Symptoms of underactive Thyroid may return if patient takes subpotent medication. Those include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of Thyroid gland and / or unexplained weight gain or difficulty losing weight. There is a 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. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these Lot numbers possibly related to this Recall. Medication was distributed Nationwide to wholesalers, pharmacies and health care offices. Earlier this month, RLC Labs Recall 483 lots of Nature-Throid and WP Thyroid because tests revealed they may not contain enough ingredients used to treat underactive Thyroid. For more information on Acella Recall, send an email to Recall acellapharma. Com or call 888-280-2044 8 am to 5 pm CT, weekdays. Portable generators sold at Sams Club, Amazon, Home Depot, Lowes Recall because of fire hazard. Magical Animal Crackers Recall because allergen is not listed on the label.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Company Announcement

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 consumer level. Products are being recalled because testing of samples from six lots by the US Food and Drug Administration found samples to be sub potent. Product may have as low as 87 % of the labeled amount of Liothyronine or Levothyroxine. Risk Statement: Patients being treated for hypothyroidism, who receive sub potent Nature-Throid or WP Thyroid, may experience signs and symptoms of hypothyroidism which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of Thyroid gland and / or unexplained weight gain or difficulty losing weight. There is a 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. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. Has not received any reports of adverse events relating to this recall. Nature-Throid and WP Thyroid are composed of Liothyronine and Levothyroxine, and are used to treat hypothyroidism. Products subject to recall are packaged in 30 60 90 100 and 1 000 count bottles. To best identify Product, NDCs, Product Descriptions, Lot Numbers and Expiration Dates are listed in below documents. These lots were distributed nationwide in the USA to RLC Labs, Inc. S direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. Is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of Product being recalled and is arranging for return of all recalled products. Patients who are currently taking Nature-Throid and WP Thyroid should not discontinue using without contacting their healthcare provider for further guidance and / or replacement prescription. Consumers with questions about recall can email RLC Labs, Inc. At recall rlclabs. Com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7: 00 am to 4: 00 pm MST and Friday from 7: 00 am to 3: 00 pm MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this Drug Product. Adverse reactions or quality problems experienced with use of this Product may be reported to FDA's MedWatch Adverse Event Reporting program either Online, by Regular Mail or by Fax. Complete and submit report Online Regular Mail or Fax: Download form or call 1-800-332-1088 to request the Reporting form, then complete and return to address on pre-addressed form, or submit by Fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the US Food and Drug Administration.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What is hypothyroidism?

Acella Pharmaceuticals is voluntarily recalling one lot of 15 mg and one lot of 120 mg Levothyroxine and liothyronine tablets due to subpotency, according to an FDA announcement. Levothyroxine and liothyronine tablets are being recalled because testing has found they may have as low as 87 % of the labeled amount of Levothyroxine, according to an agency announcement. Patients treated for Hypothyroidism who receive subpotent NP Thyroid may experience signs and symptoms of Hypothyroidism, which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of Thyroid gland and / or unexplained weight gain or difficulty losing weight, according to FDA. There is a 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. In older adults and patients with underlying cardiovascular disease, toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events. For these Lot numbers possibly relate to this recall, FDA state in announcement. Tablets are composed of Levothyroxine and liothyronine and Use to treat Hypothyroidism. Products subject to recall are packed in 100-count bottles. NP Thyroid 15 mg; NDC 42192-327-01; Lot M327E19-1; expiration date, October 2020; and NP Thyroid 120 mg; NDC 42192-328-01; Lot M328F19-3; expiration date, November 2020. Additionally, consumers may be able to determine that their product is not impacted by recall if used by, discarded after, or the expiration date on their prescription bottle is on or after December 2020, according to FDA.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Background:

WASHINGTON, DC-TWO different doses of THYROID medication are being RECALL because they're not potent enough. 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. PRODUCTS may have as low as 87 % of the labeled amount of levothyroxine, which is used TO treat hypothyroidism, according to TO FDA. The Company risk statement says patients being treated for hypothyroidism who receive sub potent NP THYROID may experience symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of THYROID gland and / or unexplained weight gain or difficulty losing weight. There is a 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, write Acella. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. So far, Acella says it has received four REPORTS of adverse events for these lot numbers, possibly related TO RECALL. PRODUCTS subject TO RECALL are packed in 100-count bottles. Their lot numbers are M327E19-1 and M328F19-3. And their expiration dates are Oct. 2020 and November 2020. PRODUCTS were distributed nationwide TO Acellas direct accounts, including wholesalers, pharmacies, and health care offices. Acella is proactively notifying ITS wholesalers by email and phone TO discontinue distribution of TWO above reference lots being RECALL and is arranging for return of all RECALL PRODUCTS, write company. Anyone who is currently taking NP THYROID from lots being RECALL should not discontinue using without contacting their health care provider for further guidance and / or replacement prescription, according TO Acella. Anyone with questions ABOUT RECALL can email Acella at RECALL acellapharma. Com or contact representative at 1-888-280-2044.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Weak thyroid medication recalled

Earlier this month, another manufacturer recalled two other brands of Thyroid medication after FDA testing found strength lacking. RLC Labs recalled 483 lots of Nature-Throid and WP Thyroid in all strengths. Company post full list of all recall lots online. At the time of that recall, Walmart put out a 68-page list of pharmacies that had either Nature-Throid or WP Thyroid, according to the Miami Herald. In risk statement from FDA, agency say that patients who are being treated for underactive Thyroid, know as hypothyroidism, and who receive sub potent NP Thyroid prescription, could experience signs and symptoms of hypothyroidism, which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of Thyroid gland and / or unexplained weight gain or difficulty losing weight.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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