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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.
Pfizer (New York) announced on Oct. 29, 2010, that it intends to recall two additional lots—approximately 38,000 bottles—of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States. The recall stems from two customer reports of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.
Pfizer said the bottles were supplied by a third-party bottle manufacturer. A medical assessment determined that the risk of health consequences to patients appears to be minimal. Pfizer said it issued the additional voluntary recall following its increased surveillance of odor-related issues based on other reports throughout the industry. The company’s increased surveillance led to two earlier recalls of Lipitor, implemented in August and October 2010, in response to infrequent complaints of uncharacteristic odor.
Pfizer said the odor is consistent with the presence of 2, 4, 6-tribromoanisole (TBA), which was found at a very low level in a complaint sample bottle during the investigation that led to the first product recall. In a company press release, Pfizer said that research indicates that a major source of TBA appears to be 2, 4, 6-tribromonophenol (TBP), a chemical used as a wood preservative. Although TBP often is applied to pallets used to transport and store products, Pfizer says it prohibits the use of TBP-treated wood in the shipment of its medicines.
Pfizer identified the source of the problem as the bottle manufacturer’s plant in Puerto Rico, which had shipped empty bottles to a Pfizer plant in Freiburg, Germany, for use in packaging Pfizer products. When the initial complaints were confirmed, Pfizer said it worked with the bottle manufacturer to put in place further quality controls to prevent TBA contamination of bottles going forward. “The company has taken quick action to ensure its product continues to meet the company’s high quality and patient safety standards,” said Pfizer in its release. “We have identified the source of the odor, and we are enacting rigorous measures to prevent odor-related issues going forward. The lots that will be recalled were packaged and shipped before these changes went into effect in August of this year.” Pfizer added that it does not anticipate a product shortage resulting from the recall. Earlier this year, Johnson & Johnson (New Brunswick, NJ) also voluntary recalled products relating to TBA contamination.
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