MICROORGANISMS INCLUDE GRAM NEGATIVE BACTERIA, YEAST AND MOLDS
On Monday, September 23, 2013 W.S. Badger Co. announced a voluntary recall of all lots of its 4-ounce Baby SPF 30 Sunscreen Lotion and one lot of its 4-ounce SPF Kids Sunscreen Lotion because of microbial contamination. The recall is being conducted with the knowledge of the U.S. food and Drug Administration.
Badger Founder & CEO Bill Whyte said in a statement “All of these lots passed the required microbiological and comprehensive challenge testing prior to sale. It was during routine re-testing that we discovered that the preservation system in several lots had been compromised. In our 18-year history, this voluntary recall is a first. We continue to conduct rigorous testing and are taking steps to ensure this doesn’t happen in the future.”
The microorganisms identified within the products during re-testing included Pseudomonas aeruginosa, Candida parapsilosis and Acremonium sp. While most know about Ps. aeruginosa, this may not be true of C. parapsilosis or Acremonium sp. C. parapsilosis is one of the leading causes of invasive candidal disease. Individuals at the highest risk for severe infection include neonates and patients in intensive care units. C. parapsilosis infections are especially associated with hyperalimentation solutions, prosthetic devices, and indwelling catheters. Acremonium sp., many of which are saprophytic, are isolated from dead plant material and soil and considered to being environmental issues. They are recognized as opportunistic pathogens of man and animals, and clinical manifestations may include arthritis, peritonitis, pneumonia and subcutaneous infection.
Several issues become of interest because of this unfortunate situation. One is a problem of USP<51> Antimicrobial Effectiveness Test — when was it last performed on these products, were the raw materials to include the preservatives still the same in terms of microbial content and efficacy as when initially formulated, when were the raw materials last investigated for microbial content, etc.
Because such a variety of microorganisms were isolated and identified, there is a definite suggestion that the in-coming raw materials and/or the plant may be contaminated. It also suggests that since a Gram negative microorganism was isolated that is associated with human contact, personnel may be an issue and require additional training is required.
In addition, with the new Process Validation Guidance from the FDA, the use of continuous monitoring within Stage 3 and the possibility for contamination reminds us that one can’t venture into “Continued Process Verification” without recognizing that this may become one of the consequences.
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