Microbial diversity in pharmaceutical product recalls and environments.

Identification of microbial contaminants in product recalls and environmental samples provides important information on the possible contamination sources and distribution of microbial species in pharmaceutical environments. Analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to September 2006 demonstrated that 48% of recalls were due to contamination by either Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti, while yeast and mold contamination were found in 23% of recalls. Gram-negative bacteria accounted for 60% of recalls, but only 4% were associated with Gram-positive bacteria. Of the 193 recalls of sterile products, 78% were due to the lack of sterility assurance and 7% for yeast and mold contamination. For sterile products, Gram-negative bacteria accounted for 6% of recalls, with only 1% due to Gram-positive bacteria. For non-sterile and sterile products, B. cepacia was the most frequently isolated microbial species with 22% and 2.5% of recalls, respectively. Based upon the review of the scientific literature, B. cepacia, Pseudomonas spp., or Ralstonia picketti may be associated with water contamination, while yeast and mold and Gram-positive bacteria may have indicated deficient environmental controls. The presence of unculturable microbial populations in pharmaceutical waters and clean rooms was reported, but no evidence has been published that product quality was negatively affected.