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
708 recalls · Class II, 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 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 II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
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 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 II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg
Failed Dissolution Specification
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specification
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Vapor Ointment packaged in a) 1/8 oz
CGMP Deviations
Class II · Moderate risk
White Liniment packaged in a) 1 oz
CGMP Deviations
Class II · Moderate risk
Union (black)
CGMP Deviations
Class II · Moderate risk
Metformin HCL E/R 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
Metformin Hydrochloride Extended Release 750 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)