Pfizer Inc. just announced that, following reports of odor, it is recalling more lots of Lipitor, a total of two lots and 38,000 bottles, said Reuters. Of note, <"http://www.yourlawyer.com/practice_areas/defective_drugs">Lipitor, the drug makerâ€™s chief cholesterol-fighting medication, is the world’s largest selling prescription drug.
It seems that chemicals used in the construction of wooden pallets were found in some Lipitor bottles that had an “uncharacteristic odor,” said Reuters. According to Pfizer, during its investigation, it found low levels of 2, 4, 6-tribromonophenol in a sample, wrote Reuters, which explained that the chemical is sometimes used on wooden pallets meant to hold cartons prior to shipment. Pfizer said that the bottles were supplied by a third-party bottle maker, added Reuters.
In the past two years, pharmaceutical giant Johnson & Johnson, has recalled millions of bottles of over-the-counter (OTC) due to odors from chemically-treated pallets that were found to have also contaminated the medications, Reuters said.
According to Pfizer, the recalled Lipitor lots were packaged and shipped prior to changes concerning the smell, said Reuters, noting that those changes were made in August; for instance, banning the use of treated pallets.
The recall, said CNN, affects Lipitor 40 mg tablets (Generic: Atorvastatin calcium) distributed in the US.
“We have thoroughly evaluated the root cause, which is episodic exposure of the bottles to low levels of TBA (tribromoanisole) as they are shipped or stored,” Pfizer said. Earlier this year, Pfizer recalled more than 190,000 bottles of Lipitor due to similar odor issues, said CNN.
“Research indicates that a major source of TBA appears to be 2, 4, 6-tribromoanisole(TBP), a chemical used as a wood preservative,” the company said. “Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilization of TBP-treated wood in the shipment of its medicines,” quoted CNN.
The US Food and Drug Adminstratio (FDA) said that reports of the contamination were linked to a “moldy or musty” odor found in food and wine products, wrote Reuters.
“Currently available data indicate that serious adverse health effects have not resulted from ingestion of drugs or foods contaminated,” the FDA said, with such compounds at the levels of contamination that have been reported.
FDA noted a connected problem. “Even if the health effects are minimal, [the] FDA is concerned that patients sensing an unusual odor that is not intrinsic to the product will stop taking their medication,” quoted CNN, citing the FDA website.