Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
In Your Face Mineral Tint SPF 31
cGMP deviations
Class II · Moderate risk
GreenScreen
cGMP deviations
Class II · Moderate risk
Erin's Faces
cGMP deviations
Class II · Moderate risk
B Natural Organics
cGMP deviations
Class II · Moderate risk
Proactiv Skin Smoothing Exfoliator
Chemical contamination: Presence of benzene
Class II · Moderate risk
Proactiv Emergency Blemish Relief
Chemical contamination: Presence of benzene
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II · Moderate risk
CVS Health Concealing Acne Treatment Cream
Chemical contamination: presence of benzene
Class II · Moderate risk
Walgreens Maximum Strength Tinted Acne Treatment Cream 10%…
Chemical contamination: presence of benzene
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
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
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Sofosbuvir and Velpatasvir
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 60 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 30 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.