Class I · High risk
Real Skill
Marketed Without An Approved NDA/ANDA
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Herb Viagra
Marketed Without An Approved NDA/ANDA
Class I · High risk
Black Ant
Marketed Without An Approved NDA/ANDA
Class II · Moderate risk
Guaifenesin DM Cherry liquid
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class II · Moderate risk
Guaifenesin Grape liquid 100 mg/5 mL
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class I · High risk
Magnesium Sulfate in Water for Injection
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness test
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
Class I · High risk
Jenesis Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk
Oasis Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk
La' Trim Plus Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.