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(USGovernment-News.Com, June 07, 2013 ) London, UK -- The Pfizer company has issued a second round of recalls for the thyroid-disease treatment known as Levoxyl in as many weeks. This time, the company stated that some tablets did not meet potency standards for the company.
Pfizer also stated that the Levoxyl drug is not available hence forth, and there may not be a return to the market for the compound for up to 18 months. Levoxyl was approved as a hypothyroidism treatment, which is a condition involving the thyroid not producing large enough quantities of necessary hormones to prevent negative effects such as goiters.
The drug maker stated that he latest recall was unrelated to a previous recall made in early March. The initial recall saw over 52,000 bottles put in question after complaints were levied regarding a plastic-like odor in the product. Pfizer stated the odor was merely oxygen-absorbing canisters, but recalled the product nonetheless.
The new recall involves 84 lots of Levoxyl, and was triggered by Pfizer's testing rounds, which found the potency of the compound was not sufficient toward the company's standards.
"Although only three batches tested for stability produced results outside of our quality specifications, as a conservative measure the company decided to recall all batches at the retail level," said spokeswoman Lauren Starr.
The necessity for the recall comes form the potency possibly carrying risk of adverse effects that result from less-than-optimal levels of the compound. There are currently alternatives to the specific product, including AbbVie's Synthroid, and other generic versions of the product.Pfizer has stated since the information regarding the recall, that Levoxyl may not be available for purchase until the middle of 2014, after all necessary evaluations are complete regarding the product. The drug has been subsequently added to the list of drugs on the Food and Drug Administration's list of drug shortages.
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