Class II · Moderate risk
Testosterone Micronized
cGMP Deviations; lack of quality assurance.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Micronized Bulk
cGMP Deviations; lack of quality assurance.
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.
Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk
CLENZIderm M.D. Acne Treatment System
Discoloration.
Class III · Low risk
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk
Fluocinonide Cream UPS
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluphenazine Decanoate Injection
Subpotent Drug
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications; 9 month long term stability