Class II · Moderate risk
Man Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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
Rejuvenation Plus
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Healthful Naturals Leg Cramp Support Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Healthful Naturals DizziFree Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I · High risk
Native Remedies EyeClear Pro Oral Spray
Microbial Contamination of Non-Sterile Product
Class I · High risk
Native Remedies VaricoGo Oral Spray
Microbial Contamination of Non-Sterile Products
Class I · High risk
Native Remedies HypoSlim Oral Spray
Microbial Contamination of Non-Sterile Products
Class I · High risk
Native Remedies VertiFree Oral Spray
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
SparkleFresh Fluoride Toothpaste
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Arthritis Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Colds & Flu Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Allergy & Hay Fever Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Muscle & Joint Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Diarrhea Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sore Throat & Laryngitis Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sinus Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Skin Irritation & Itch Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Cortaid 12-Hour Advanced Anti-itch Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Maximum Strength Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Intensive Therapy Cooling Spray
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class I · High risk
Respitrol
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk
Thyroveev
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk
Neuroveen
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk
Compulsin
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk
Living Well Remedies Weight Away Remedy
Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
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