Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
FDA Drug Recalls
18,003 recalls, newest first
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 III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
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
Class II · Moderate risk
Absorbine Jr Pain Relieving Knee Patch
cGMP Deviations
Class II · Moderate risk
ABSORBINE jr ULTRA STRENGTH PAIN PATCH
cGMP Deviations
Class II · Moderate risk
ABSORBINE jr. Extra Large BACK PATCH
cGMP Deviations
Class II · Moderate risk
Ramipril Capsules USP 10 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor