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Patricia Van Arnum was executive editor of Pharmaceutical Technology
Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.
King Pharmaceuticals , a wholly owned subsidiary of Pfizer, has initiated a voluntary recall of Levoxyl (levothyroxine sodium), which is used to treat hypothyroidism and certain types of goiter.
The company initiated the recall after learning of complaints from pharmacists and patients of an uncharacteristic odor coming from Levoxyl bottles. It was determined that the odor was caused by an oxygen-absorbing canister added to 100- and 1000-tablet pharmacy bottles to enhance the stability of the product, according to a company statement.
“Pfizer conducted a careful health assessment of the situation and concluded that this odor is not likely to cause any adverse health consequences,” said the company in its statement. “However, the company discussed this situation with the US Food and Drug Administration and decided, out of an abundance of caution, to voluntarily recall the product at the retail level.”
Levoxyl is an oral tablet used used as replacement or supplemental therapy in low thyroid function (hypothyroidism) of any cause, except transient hypothyroidism during the recovery phase of subacute thyroiditis. It is also used in the treatment or prevention of certain types of goiters and, as additional therapy, in the management of a specific thyroid cancer.
King Pharmaceuticals and Pfizer said they are working to resolve the issue as quickly as possible although it is anticipated that the company may not be able to restart production until 2014. The information was posted on FDA’s Drug Shortages website as well.