Class II · Moderate risk
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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
Soothe & Cool Protect Moisture Guard Skin Protectant
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Germ Bloc Health Hand Sanitizer Foam
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk
Alcohol Free Foaming Hand Sanitizer
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
deb stoko
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
Diet Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Body Balance
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Acne Tonic Homeopathic Oral Spray 1.38 fl. oz.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Body Skin Tonic
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
ImmunoBooster
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Life Detoxer Homeopathic Oral Spray 1.38 fl. oz.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
PMS Support
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Stress Relief
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Snore Soother
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Arnica Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Party Relief
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
TravelEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
SleepEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
DigestivEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Cold + Flu Relief
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
AllergEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Bone Builder
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
MenoPower
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Woman Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Brain Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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