Medicine recalls
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| The United States: Acella Pharmaceuticals, LLC issues voluntary nationwide recall of certain lots of NP Thyroid® (Thyroid Tablets, USP) due to sub potency |
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The US Food and Drug Administration (FDA) announces that Acella Pharmaceuticals, LLC is voluntarily recalling certain lots of 15mg, 30mg, 60mg, 90mg and 120mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4). For details of the affected lots, please refer to the website in 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. To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid-0
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Monday, May 3, 2021
Issued at HKT 15:00
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