Class II · Moderate risk Terminated
Cooling Menthol Extra Strength Pain Relief Patch
Reason cGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Xelstrym
Reason Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk Ongoing
Regadenoson Injection
Reason Labeling: Missing Label
Class III · Low risk Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason 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 Terminated
Lisdexamfetamine Dimesylate Capsules
Reason Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II · Moderate risk Terminated
Parche Leon Pain Relieving Hot Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
Cheeky Bonsai Pain Relief Patches
Reason cGMP Deviations
Class II · Moderate risk Terminated
Jr Watkins Cooling Pain Relief Patches
Reason cGMP Deviations
Class II · Moderate risk Terminated
LILAS Feminine Pain Relief Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine…
Reason cGMP Deviations
Class II · Moderate risk Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief
Reason cGMP Deviations
Class II · Moderate risk Terminated
THERACARE Cold Hot Medicated Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
Absorbine Jr Pain Relieving Knee Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr. Extra Large BACK PATCH
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ramipril Capsules USP 10 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 5 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 2.5 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg
Reason Failed Impurities/Degradation Specification