Issue



Fungal contamination prompts diabetes treatment recall


11/01/2001







Mark A. DeSorbo

Kalamazoo, MI—Pharmacia Corp. has voluntarily recalled three lots of its diabetic treatment, Micronase, after in-house tests on three separate strengths of tablets revealed fungal contamination.

A U.S. Food and Drug Administration (FDA) recall notification indicated that, paecilomyces, aspergillus and penicillium molds were detected, and the source of the contamination was traced to a "raw material" used in the formulation of Micronase 1.25-, 2.5- and 5-mg tablets.

Stephen Lederer, Pharmacia's communications director, would not provide details about the raw material except to say that it came from a third-party processor, who he declined to identify.

The contamination, Lederer says, was found during an in-house inspection of Micronase lots. The data from that investigation was shared with FDA compliance officers during a routine inspection.

Under FDA current Good Manufacturing Practices (cGMPs), low levels of fungi may be permissible, depending on the product. However, in view of the intended use of the product, trends of objectionable contamination from either a third-party processor or within the manufacturing facility indicate unsanitary conditions, warranting a product recall.

Pharmacia's Micronase lots, Lederer says, were found to have varying levels of molds. "The levels are at issue, and that's why the FDA asked us to recall the product," he adds. "The greatest risk to patients would be to stop taking the medication. We don't know of a specific risk of ingesting this fungus. The fungus cannot thrive in the digestive tract."

Molds, however, do produce byproducts, including toxins and allergens that can affect safety and efficacy of drugs. The FDA recall-notification did indicate that paecilomyces, aspergillus and penicillium have, in rare cases, caused sinus or lung infections if inhaled and cellulites if it enters damaged skin.

Other recalls noted by the FDA include:

  • Hot smoked salmon was distributed by Pacific Shellfish (San Diego) and recalled by Ghio Seafood Products (San Diego) for listeria monocytogenes contamination.
  • Halved and seeded red bell peppers in five-pound plastic bags were contaminated with listeria monocytogenes and 20 cases totaling 200 pounds were recalled by Farmer's Best International LLC (Rio Rico, CA).
  • A recall of 770 bottles of Trav-l-Tabs (Meclizine HCl) 25 mg tablets was conducted by Wendt Laboratories Inc. (Belle Plaine, MN) after a deviation in production validation.
  • Bareman Dairy (Holland, MI) recalled 19,700 gallons of its Crystal Clear Drinking Water that was packaged in 1-gallon containers. Bareman Dairy determined that a portion of this lot contains equipment sanitizer. This sanitizer is made of a mix of peroxiacetic acid and hydrogen peroxide.