Class II · Moderate risk
Walgreens Maximum Strength Tinted Acne Treatment Cream 10%…
Chemical contamination: presence of benzene
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
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.
Class II · Moderate risk
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
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.
Class II · Moderate risk
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Unisom
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class II · Moderate risk
Carvedilol Tablets USP 25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 12.5 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 6.25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit