Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class II · Moderate risk Terminated
Buprenorphine HCl Injection
Reason Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk Terminated
Volu-Sol Handrub Sanitizing Solution
Reason Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets
Reason Failed Impurity /Degradation Specifications
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk Terminated
Prednisone Tablets
Reason Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk Terminated
Just Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
Always Be Clean Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
UltraCruz Hand Sanitizing Gel Antimicrobial
Reason Subpotent drug
Class I · High risk Terminated
Incredible Products Gelbac T Antibacterial Hand Gel
Reason Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk Terminated
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ketamine 50 mg Infusion
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL 250 mL bags
Reason Lack of Assurance of Sterility