Happi staff10.18.19
Johnson & Johnson Consumer Inc. (JJCI) said that “out of an abundance of caution,” it has initiated a voluntary recall in the United States of a single lot of its Johnson's Baby Powder in response to a US Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination (no greater than 0.00002%) in samples from a single bottle purchased from an online retailer. Despite the low levels reported and in full cooperation and collaboration with the FDA,
JJCI is initiating this voluntary recall of Lot #22318RB of Johnson's Baby Powder, from which the tested sample was taken.
The recall limited to one lot of bottles produced and shipped in the US in 2018
In parallel, JJCI said it has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results.
At this early stage of the investigation, JJCI:
• Cannot confirm if cross-contamination of the sample caused a false positive.
• Cannot confirm whether the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
• Cannot confirm whether the tested product is authentic or counterfeit.
According to J&J, "JJCI has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA's own testing on prior occasions—and as recently as last month—found no asbestos. A recall statement from the company noted; “Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities."
JJCI is initiating this voluntary recall of Lot #22318RB of Johnson's Baby Powder, from which the tested sample was taken.
The recall limited to one lot of bottles produced and shipped in the US in 2018
In parallel, JJCI said it has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results.
At this early stage of the investigation, JJCI:
• Cannot confirm if cross-contamination of the sample caused a false positive.
• Cannot confirm whether the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
• Cannot confirm whether the tested product is authentic or counterfeit.
According to J&J, "JJCI has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA's own testing on prior occasions—and as recently as last month—found no asbestos. A recall statement from the company noted; “Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities."
