Yeast Arrest
cGMP violations
Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Cause type: 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. All microbial contamination recalls.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
cGMP violations
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Microbial Contamination of Non-Sterile Products
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