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“Particulate matter” cited in Luitpold and Cumberland recalls

By Gareth Macdonald , 03-Jan-2011

US drugmakers Luitpold and Cumberland have both withdrawn injectable pharmaceutical products after contamination concerns.

First up is Luitpold Pharmaceuticals, which recalled lots of dexamathasone sodium phosphate and sodium bicarbonate after detecting what it described as “particulate matter” in the products’ vials.

 

According to Luitpold the withdrawal, which began in December in partnership with its distribution arm American Regent, was initiated because the contaminants have the potential to damage blood vessels in the lung and cause granulation formation.

 

Company CEO Mary Jane Helenek said: “All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients.”

 

She added that the Shirely, New York-headquartered drugmaker is investigating the issue and has informed the US Food and Drug Administration (FDA).

 

The firm, which is a subsidiary of Japanese drugmaker DaiChii Sankyo, issued a similar recall in October last year when it pulled a single lot of its magnesium sulphate injection product after detecting iron particles in vials.

 

Cumberland withdraws acetadote

 

Tennessee-based Cumberland Pharma also cited contamination as the key driver for its recall when it pulled six lots of its liver injury treatment Acetadote last month.

 

In a letter published on December 30 Cumberland said it was recalling the drugs as a precautionary measure after observing “particulate matter” in a “very small” number of vials.

 

And, although specifics were not provided, the firm said that the particles came from the glass vials used to package the product by a former supplier.

CEO AJ Kazimi explained that: “As part of ongoing quality assessment, we switched to a new vial packaging supplier in August of 2009,” adding that “[we] believe the risk of any serious adverse medical events to be remote.”

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