Class II · Moderate risk
Vivier Sheer SPF 30 Mineral With Antioxidants
Microbial Contamination of Non-Sterile Product
FDA Drug Recalls
23 recalls · Class II, newest first
Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 120mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 80 mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Cinacalcet Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.