Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
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