Abstract
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.
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.