The US CPSC issued a recall for multi-purpose cleaner earlier this month (Feb 8th 2023) due to bacterial contamination risks. Although this is just a single recall event currently, it involves 9 different SKUs and it affects not only the US (4.9 million units) but also Canada too (56 thousand units). The main bacterial contaminants listed were Pseudomonas Species. This species are found quite ubiquitously in the environment however if inhaled or absorbed across skin membranes or wounds they may cause serious infections that can require medical treatment.
It is interesting that this is now the 4th high volume recall of this nature in the last 12 months. Each of these bacterial contamination events were from both a different brand owner to the previous incidents and manufacturers’ city location however the similarities cannot go unnoticed. Although the brands are all big, respectable household names in each case, manufactured and/or owned by some key players in the consumer goods and household chemical production sphere, it is clear that these types of incidents are still able to happen.
As this is an environmental organism the possibilities of root cause inoculum of product or facility are long and it is especially important to pay close attention to cGMPs and good hygiene practises; yes you even need to clean up after cleaning products! Water is a common source of this organism however there are now questions to be asked with these recalled manufacturers’ facilities being geographically isolated – could this be a common mis-practice that’s found its way into the industry or is there a chance of a shared raw material carrying an inherent risk? It would be interesting to see the genetic fingerprinting of the organisms in each case by a method such as Next Generation Sequencing (NGS) to get to the bottom of this to help find the root cause.
In summary, it is always important to assess new and emerging risks and to keep good manufacturing practices up to date. We hope that the root cause of the source of this bacterial contamination is found and can be controlled and that it is shared within the industry to allow for rigour to be applied, set a new benchmark for best practice and therefore result in a significant reduction in future product recalls of this nature.
RQA Group can assist you to review your cGMPs, product risk assessments and microbiological & chemical surveillance programs. Click here for more on our services for product manufacturers.
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