Class II · Moderate risk
Kroger Jock Itch Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Kroger Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kaiser Permanente Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Equate Athlete's Foot
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
CVS Health Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kollidon CL-M Crospovidone Ph.Eur.Type B
Cross contamination: the excipient was found to be contaminated with theophylline.
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk
Aripiprazole Tablets
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class III · Low risk
Levocetirizine Dihydrochloride Tablets
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class III · Low risk
Testosterone Gel 1%
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
Class III · Low risk
Clobetasol Propionate Ointment USP 0.05%
Superpotent and Subpotent; low and high assay results
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk
Metformin HCl Extended Release Tablets USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class I · High risk
Paroex (chlorhexidine gluconate)
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg
Failed Dissolution Specification