Class II · Moderate risk
Stage 2-Ophardt Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
Class II · Moderate risk
Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class I · High risk
CVS Health Magnesium Citrate SALINE LAXATIVE
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class I · High risk
SnoreStop NasoSpray
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class I · High risk
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
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.
Class I · High risk
Magnesium Hydroxide 2400 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Magnesium Hydroxide 1200 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Earache Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Ear Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk
Magnesium Hydroxide 1200mg
Microbial Contamination of Non-Sterile Products
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class I · High risk
SyrSpend SF Suspending Base
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk
Hcg 6
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I · High risk
Revitaderm Wound Care Gel
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
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