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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 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
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
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
Class II · Moderate risk
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification