Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Calcium Carbonate Chewable 500 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Aspirin Chewable tablet 81 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Vitamin B1
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Vitamin D3
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent drug
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Compliance Dishwashing Liquid & Antibacterial Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Genuine Joe Antibacterial Lotion Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
ROYALAB Germ Away Antibacterial Hand Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Array Liquid Antiseptic Handwash
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
boardwalk ANTIBACTERIAL HANDSOAP REFILL
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
MAXIM Assure Antibacterial
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Bevacizumab
Lack of Sterility Assurance
Class II · Moderate risk
Trinity Gold Nutrition
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class III · Low risk
Hydralazine HCl Tablets
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class I · High risk
ZapMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
ZoomMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
PeakMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
VitalityXtra Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.