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 super potency |
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The US Food and Drug Administration (FDA) announces that 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. The products are being recalled because the testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid).
The affected products are:
- NP Thyroid 30 mg (NDC: 42192-329-01)
- NP Thyroid 60 mg (NDC: 42192-330-01)
- NP Thyroid 90 mg (NDC: 42192-331-01)
Please refer to the FDA website for the affected lot numbers.
Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to 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
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Saturday, May 23, 2020
Issued at HKT 12:00
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