Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
46 recalls, newest first
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Microbial Contamination of Non-Sterile Products.
Microbial Contamination of Non-Sterile Products.
Microbial Contamination of Non-Sterile Products.
Microbial Contamination of Non-Sterile Products
Microbial contamination of non-sterile product.
Microbial contamination of non-sterile product.
Microbial contamination of non-sterile product.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
CGMP Deviations: Failure to properly investigate failed microbial testing.
CGMP Deviations: Failure to properly investigate failed microbial testing.
CGMP Deviations: Failure to properly investigate failed microbial testing.
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.