Pfizer Widens Recall of Lipitor Bottles
Pfizer Widens Recall of Lipitor Bottles
Pfizer Inc. again widened a recall of its blockbuster cholesterol-lowering drug Lipitor due to reports of musty or moldy odors associated with the product.
The New York drug maker said Friday it plans to recall about 38,000 bottles of Lipitor 40-milligram tablets that were distributed in the U.S. Pfizer cited two customer reports of an uncharacteristic odor related to the bottles, which Pfizer said were supplied by a third-party bottle manufacturer.
The latest incident follows two prior recalls of Lipitor implemented in August and earlier this month, which were also linked to complaints of unusual odor. About 332,000 bottles of Lipitor were recalled in those incidents combined.
Pfizer cautioned that additional recalls may be necessary because products manufactured before it made certain production changes could still be on the market.
The Pfizer recall continues a string of manufacturing-quality problems in the drug industry. Johnson & Johnson has made a series of recalls of over-the-counter medicines in the past year, including recalling Tylenol due to reports of musty or moldy odors. And this week GlaxoSmithKline PLC agreed to pay $750 million and plead guilty to a criminal charge to settle a government probe of manufacturing deficiencies at a plant in Puerto Rico, which distributed adulterated drugs.
Pfizer said Friday the odor is consistent with the presence of a chemical called 2,4,6tribromoanisole, or TBA, which was found at a very low level in a complaint sample bottleduring the probe that led to the first recall. TBA is used as a wood preservative on pallets to transport and store products.
The same chemical was implicated in J&J's Tylenol recalls linked to unusual odors. Pfizer said it stepped up its monitoring of possible TBA-related odor problems earlier this year.
The lots in the latest Lipitor recall were packaged and shipped before Pfizer made certain changes in August intended to avoid the odor problem.
Pfizer spokesman Ray Kerins said the company has taken steps to reduce risk of TBA contamination, including requiring the use of plastic pallets for transport of empty bottles.
Pfizer has identified the source of the problem as the bottle manufacturer's plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany, for use in Pfizerproducts. Mr. Kerins said bottle production has been shifted to alternate third-party plants.
Lipitor is the best-selling prescription drug in the world, generating $5.57 billion in sales for the first half of 2010. Pfizer is scheduled to report third-quarter results next week.
Pfizer Inc. again widened a recall of its blockbuster cholesterol-lowering drug Lipitor due to reports of musty or moldy odors associated with the product.
The New York drug maker said Friday it plans to recall about 38,000 bottles of Lipitor 40-milligram tablets that were distributed in the U.S. Pfizer cited two customer reports of an uncharacteristic odor related to the bottles, which Pfizer said were supplied by a third-party bottle manufacturer.
The latest incident follows two prior recalls of Lipitor implemented in August and earlier this month, which were also linked to complaints of unusual odor. About 332,000 bottles of Lipitor were recalled in those incidents combined.
Pfizer cautioned that additional recalls may be necessary because products manufactured before it made certain production changes could still be on the market.
The Pfizer recall continues a string of manufacturing-quality problems in the drug industry. Johnson & Johnson has made a series of recalls of over-the-counter medicines in the past year, including recalling Tylenol due to reports of musty or moldy odors. And this week GlaxoSmithKline PLC agreed to pay $750 million and plead guilty to a criminal charge to settle a government probe of manufacturing deficiencies at a plant in Puerto Rico, which distributed adulterated drugs.
Pfizer said Friday the odor is consistent with the presence of a chemical called 2,4,6tribromoanisole, or TBA, which was found at a very low level in a complaint sample bottleduring the probe that led to the first recall. TBA is used as a wood preservative on pallets to transport and store products.
The same chemical was implicated in J&J's Tylenol recalls linked to unusual odors. Pfizer said it stepped up its monitoring of possible TBA-related odor problems earlier this year.
The lots in the latest Lipitor recall were packaged and shipped before Pfizer made certain changes in August intended to avoid the odor problem.
Pfizer spokesman Ray Kerins said the company has taken steps to reduce risk of TBA contamination, including requiring the use of plastic pallets for transport of empty bottles.
Pfizer has identified the source of the problem as the bottle manufacturer's plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany, for use in Pfizerproducts. Mr. Kerins said bottle production has been shifted to alternate third-party plants.
Lipitor is the best-selling prescription drug in the world, generating $5.57 billion in sales for the first half of 2010. Pfizer is scheduled to report third-quarter results next week.
Source...