Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Genuine Joe Antibacterial Lotion Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
ROYALAB Germ Away Antibacterial Hand Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Array Liquid Antiseptic Handwash
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
boardwalk ANTIBACTERIAL HANDSOAP REFILL
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
MAXIM Assure Antibacterial
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Trinity Gold Nutrition
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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 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 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
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up