Acella Pharmaceuticals, LLC recalls 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.
According to FDA, Acella recalls of the drug connected with its low effectiveness. Product can consist only 87% of the labeled amount of levothyroxine (T4), which does not respond to the marking on the package.
How To Identify What Acella Recalls
Food and Drug Administration of U. S. found the best way of how to identify recalled product. The NDC’s, Product Description, Lot Numbers and Expiration Dates are listed, all these sings can be a marker of not qualitative drug. Besides, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.
Acella said, that “lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.”
NP Thyroid, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. The current images of recalled product and main marking aspects of it customers can find on FDA website.
Company notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients, who already got the medicine no need to immediately stop taken the drug, but at firs is recommended to contacting their healthcare provider for further guidance and/or a replacement prescription.
Possible Risks
According to FDA “Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may 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.
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. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”
Need to be said that at 21 May 2020, Acella Pharmaceuticals, LLC is voluntarily recalled a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid. The products were recalled because testing has found these lots to be superpotent. The product may have had up to 115.0% of the labeled amount of Liothyronine (T3).
Clients, who bought recalled product can email Acella Pharmaceuticals at recall@acellapharma.com or contact to representatives at 1-888-280-2044; 1-888-280-2044, Monday through Friday from 8:00 am to 5:00 pm ET, as company posts.
FDA, in their turn, encourage customers to report online on their mail or fax with submit forms. If you’re using regular mail or fax, you should download special form or call 1- 800-332-1088; 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178; 1-800-FDA-0178.
