Class II · Moderate risk
Array Liquid Antiseptic Handwash
cGMP Deviations: Out of specification results for micro in hand soap products.
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
boardwalk ANTIBACTERIAL HANDSOAP REFILL
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
MAXIM Assure Antibacterial
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Bevacizumab
Lack of Sterility Assurance
Class II · Moderate risk
Trinity Gold Nutrition
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Cooling Menthol Extra Strength Pain Relief Patch
cGMP Deviations
Class II · Moderate risk
Xelstrym (dextroamphetamine)
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk
Regadenoson Injection
Labeling: Missing Label
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Timolol Maleate 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
Lisdexamfetamine Dimesylate Capsules
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II · Moderate risk
Parche Leon Pain Relieving Hot Patch
cGMP Deviations
Class II · Moderate risk
Cheeky Bonsai Pain Relief Patches
cGMP Deviations
Class II · Moderate risk
Jr Watkins Cooling Pain Relief Patches
cGMP Deviations
Class II · Moderate risk
LILAS Feminine Pain Relief Patch
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
HealthWise PERIOD PATCH Menstrual Pain Relief
cGMP Deviations
Class II · Moderate risk
THERACARE Cold Hot Medicated Patch
cGMP Deviations
Class II · Moderate risk
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
cGMP Deviations