Class II · Moderate risk Ongoing
CVS Health Concealing Acne Treatment Cream
Reason Chemical contamination: presence of benzene
FDA Drug Recalls
17,898 recalls, newest first
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.
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual…
Reason 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 Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
Reason 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 Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual…
Reason Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Prasugrel Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class III · Low risk Ongoing
Gabapentin Capsules
Reason Cross Contamination
Class III · Low risk Ongoing
Gabapentin Capsules
Reason Cross Contamination
Class III · Low risk Terminated
Tolterodine Tartrate Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.