Westminster Pharmaceuticals announced the recall of two thyroid tablets due to the risk of adulteration.
According to the FDA, levothyroxine and liothyronine, which are used to treat hypothyroidism contain adulterants or contaminants.
However, the announcement dated August 9, 2018, also stated that there was no reported illness with the medication.
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The agency has said that patients can continue to take the tablets until they get a replacement. These pills are used to treat severe conditions.
The company was voluntarily recalling its products. The step was a precautionary measure as they were manufactured using ingredients sourced from Sichuan Friendly Pharmaceutical Co., Ltd, China.
The FDA had listed in June 2018 that the company did not meet the strict manufacturing guidelines set by the agency.
The letter said that the company failed on some counts, including the ones related to “established standards of quality and purity.”
Drug manufacturing companies are required to document the testing and procedures to ensure the quality of the medication.
Westminster Pharmaceuticals notified its distributors by email and phone to discontinue the supply of the product and also to make arrangements for their return.
“Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.”
Press Release, FDA, August 9, 2018.
However, FDA also made it clear that patients who are taking the tablets must contact their physician before deciding to discontinue them.
In case of medical-related questions, consumers can contact Westminster’s Regulatory Affairs Department on 888-354-9939 from Monday to Friday between 9 A. and 5 P.M. Customers can also email their queries to firstname.lastname@example.org.
According to CNBC, the thyroid is responsible for many aspects of metabolism. Hypothyroidism is a condition which produces lower levels of hormones leading to weight gain, fatigue, feeling cold, constipation, joint pain, depression, dry skin, and heavier periods.
It is more common in women than in men with five out of every 100 people in the US having the condition.
The company sold the tablets in 100-count bottles in 15-, 30-, 60-, 90-, and 120-mg doses. The expiration dates of the medication are in 2019 and 2020.
The complete list of the recalled products is available on the federal agency’s website.
Recently, another medication was recalled as it posed a potential cancer risk. Valsartan, which used to treat high blood pressure and congestive heart failure, did not meet high-quality standards, according to Edition.com.
The company which originally developed the medication, Novartis, had declared that it was off-patent and was being used as a component in other medicines.
Sandoz valsartan and valsartan/HCT film-coated tablets were recalled throughout the UK, according to a report on July 6, 2018.
The recall was also for batches that were sent outside of the UK including Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, and several other European countries.