Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
FDA Drug Recalls
17 recalls · Class II, newest first
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.
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.