Pfizer says low levels of 2,4,6 tribromoanisole were detected in seven lots of the cholesterol buster, Lipitor, that it recalled in August.
The recall, news of which was announced by the US drug giant late last week, involved 191,000 bottles of the world's best selling drug after a number of patients reported a “musty odour” when opening the product.
Rick Chambers, a Pfizer spokesperson told in-PharmaTechnologist that although “2,4,6 tribromoanisole was detected at very low levels in a sample from one of the lots, it isn’t confirmed whether that is the source of the odour.” He added that the investigation into the cause of the odour is still ongoing.
“The problem appears to be with the bottles that we received from a third-party supplier,” continued Chambers, who did not name the firm involved.
Health problem was “unrelated”
The recall came after three consumers complained about the musty odour; one of whom filed an adverse event report. Chambers, however, said the consumer’s health problem was probably unrelated and “[Pfizer’s] medical assessment determined that it is not likely to be associated with the odour.”
Chambers also reiterated that “the odor is associated with the bottles, not with the product,” continuing to say, “we are working with the bottle supplier to determine the problem and assure that corrective measures are taken.”
The company is dealing with the situation, which is now being monitored by the US Food and Drug Administration (FDA), by “changing the way that the bottles are packaged at the bottle supplier, decreasing time to delivery, and relocating some bottle production to other facilities operated by the supplier,” said Chambers.
Pfizer’s Lipitor drug remains the world’s top-selling prescription medicine, with annual sales exceeding $11bn, although the company faces loss of the drug’s patent protection next year. Despite this, Chambers said, “Our focus is on maintaining the high standard of quality for our products and assuring patient safety.”
This is not the first time “musty odours” have wafted into the world of big pharma. In 2009, Johnson & Johnson were forced to recall massive quantities of its Tylenol brand acetaminophen products for the same reason. The Tylenol odour problem at Johnson & Johnson later became the subject of an FDA criminal investigation.
New Wuhan R&D centre
In other news, Pfizer revealed that it has established a global research and development centre for radiation biology and drug development in Wuhan, the capital of China’s Hubei Province.
Pfizer’s Wuhan R&D centre will support the firm’s global clinical development projects, including clinical trials from Phase I to Phase IV, as well as collaborating with local institutions to put training programs in place. The company aims to increase the number of employees at the new R&D centre from 40 to over 200 by 2012.