Pfizer ($PFE) began recalling its thyroid drug Levoxyl this year after getting complaints of odors from the bottles tied to a new formulation, a move that threatened to lead to a shortage of the drug. So its King Pharmaceuticals subsidiary returned to making the older formulation. But now it has to recall 84 lots of that product because there appears to be potency issues.
The company sent a letter late last month saying the product was showing lower-than-expected results, a problem that could lead to health problems. "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," Pfizer spokeswoman Lauren Starr told Dow Jones.
A Pfizer spokeswoman told Medscape Medical News that the company does not expect to be able to supply the drug again until 2014. Levoxyl, a replacement or supplemental therapy in some hypothyroidism, has been put on the FDA's drug shortage list. Pfizer acquired Levoxyl with its $3.6 billion purchase of King Pharmaceuticals in 2011. "There are two formulations, and there are no plans to reintroduce the older formulation," Starr said.
King earlier recalled 52,000 bottles of Levoxyl because of a bad odor. The company started hearing complaints in February and tracked the problem to the oxygen-absorbing canisters in 100-count and 1,000-count bottles. The company said in the first Dear Doctor letter that the "odor is not likely to cause any adverse health consequences. However, the company discussed this situation with the FDA and decided, out of an abundance of caution, to voluntarily recall all strengths of Levoxyl." Last year, Pfizer recalled more than 650,000 bottles of Advil gel tabs from stores because they had a strong odor.