WASHINGTON (AP) — Drugmaker Pfizer Inc. announced Friday it would recall 38,000 bottles of its blockbuster cholesterol drug Lipitor due to an unpleasant odor, the third recall this year related to the problem.
The New York-based drugmaker said the latest recall was triggered by two consumer complaints about a musty or moldy odor on Lipitor bottles, which are made by an outside company in Puerto Rico.
Pfizer has recalled over 360,000 bottles of Lipitor in the last three months because of the issue. The company recalled 140,000 bottles in August and another 191,000 earlier this month.
Friday's action affects two product lots.
Similar complaints have triggered multiple recalls by competitor Johnson & Johnson in the past year. While patients have reported nausea and diarrhea after using those products, the risk of serious harm is remote, according to a memo from the Food and Drug Administration.
As with the J&J; recalls, Pfizer said the issue was caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is used to treat wooden pallets often used to store and ship bottles.
Pfizer said its inspectors found the chemical in packaging materials and wooden pallets at the Puerto Rican plant which supplies its bottles.
"We have identified the source of the odor and we are enacting rigorous measures to prevent odor-related issues going forward," the company said in a statement.
The company warned that there could be additional recalls of products previously shipped from the plant. However, no bottles have tested for the odor since changes were made in August, according to Pfizer.
"We have taken action to preserve product quality and patient trust," said company spokesman Ray Kerins. He added that any Lipitor user who encounters the odor can have their bottle replaced at the pharmacy at no charge.
Lipitor is the best-selling prescription medication in the U.S., with $7.5 billion in sales last year, according to health care data firm IMS Health.
New Brunswick, N.J.-based J&J; has seen its reputation battered in the past year over more than a dozen product recalls. Five of those actions involved odor issues reported with Tylenol, Benadryl and other household brands.
The New York-based drugmaker said the latest recall was triggered by two consumer complaints about a musty or moldy odor on Lipitor bottles, which are made by an outside company in Puerto Rico.
Pfizer has recalled over 360,000 bottles of Lipitor in the last three months because of the issue. The company recalled 140,000 bottles in August and another 191,000 earlier this month.
Friday's action affects two product lots.
Similar complaints have triggered multiple recalls by competitor Johnson & Johnson in the past year. While patients have reported nausea and diarrhea after using those products, the risk of serious harm is remote, according to a memo from the Food and Drug Administration.
As with the J&J; recalls, Pfizer said the issue was caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is used to treat wooden pallets often used to store and ship bottles.
Pfizer said its inspectors found the chemical in packaging materials and wooden pallets at the Puerto Rican plant which supplies its bottles.
"We have identified the source of the odor and we are enacting rigorous measures to prevent odor-related issues going forward," the company said in a statement.
The company warned that there could be additional recalls of products previously shipped from the plant. However, no bottles have tested for the odor since changes were made in August, according to Pfizer.
"We have taken action to preserve product quality and patient trust," said company spokesman Ray Kerins. He added that any Lipitor user who encounters the odor can have their bottle replaced at the pharmacy at no charge.
Lipitor is the best-selling prescription medication in the U.S., with $7.5 billion in sales last year, according to health care data firm IMS Health.
New Brunswick, N.J.-based J&J; has seen its reputation battered in the past year over more than a dozen product recalls. Five of those actions involved odor issues reported with Tylenol, Benadryl and other household brands.
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