Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Umary Acid Hyaluronic
Reason cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Class III · Low risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Kissable Diabetics Foot Cream
Reason CGMP Deviations: lack of adequate release testing.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Docusate Sodium 250 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Calcium Carbonate Chewable 500 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Aspirin Chewable tablet 81 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin B1
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin D3
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent drug
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
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.