Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
FDA Drug Recalls
9 recalls, newest first
Class I · High risk
Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk
Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk
BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Zep, Alcohol Sanitizer Spray
Microbial contamination of sterile products
Class I · High risk
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class II · Moderate risk
Semaglutide
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Class II · Moderate risk
Semaglutide
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution