Class II · Moderate risk Ongoing
Voriconazole Tablets 50mg
Reason CGMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Voriconazole Tablets 200 mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Solifenacin Succinate Tablets 10MG
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 325mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 225mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Fenofibrate Capsules 67 mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
In Your Face Mineral Tint SPF 31
Reason cGMP deviations
Class II · Moderate risk Ongoing
GreenScreen
Reason cGMP deviations
Class II · Moderate risk Ongoing
Erin's Faces
Reason cGMP deviations
Class II · Moderate risk Ongoing
B Natural Organics
Reason cGMP deviations
Class II · Moderate risk Ongoing
Proactiv Skin Smoothing Exfoliator
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
Proactiv Emergency Blemish Relief
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
CVS Health Concealing Acne Treatment Cream
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10%…
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
Duloxetine D/R
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine D/R
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Sofosbuvir and Velpatasvir
Reason Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II · Moderate risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Reason Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk Completed
Cinacalcet Hydrochloride Tablets 60 mg
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk Completed
Cinacalcet Hydrochloride Tablets 30 mg
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.