Class I · High risk Terminated
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Reason Superpotent Drug
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
DDAVP Nasal Spray
Reason Superpotent Drug
Class II · Moderate risk Terminated
Mibelas 24 Fe
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk Terminated
Fentanyl Citrate Inj.
Reason Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk Terminated
HGH Vitality Homeopathic
Reason Labeling: Error on Declared Strength
Class II · Moderate risk Terminated
Bersih Hand Sanitizer Gel
Reason cGMP Deviations
Class II · Moderate risk Terminated
Lidocaine Patch 5%
Reason Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class III · Low risk Terminated
Fosaprepitant for Injection
Reason Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Class II · Moderate risk Terminated
Hydrocortisone butyrate Cream
Reason SUBPOTENT DRUG
Class I · High risk Terminated
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk Terminated
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk Terminated
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class II · Moderate risk Terminated
Modesa instant HAND SANITIZER with moisturizers & vitamin E
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
ASSURED Instant Hand Sanitizer Aloe & Moisturizers
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
ASSURED Instant Hand Sanitizer Vitamin E and Aloe
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen ADVANCED HAND SANITIZER
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.