Class II · Moderate risk
Mibelas 24 Fe
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk
Fentanyl Citrate Inj.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk
HGH Vitality Homeopathic
Labeling: Error on Declared Strength
Class II · Moderate risk
Bersih Hand Sanitizer Gel
cGMP Deviations
Class II · Moderate risk
Lidocaine Patch 5%
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class III · Low risk
Fosaprepitant for Injection
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
Hydrocortisone butyrate Cream
SUBPOTENT DRUG
Class I · High risk
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class II · Moderate risk
Modesa instant HAND SANITIZER with moisturizers & vitamin E
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
ASSURED Instant Hand Sanitizer Aloe & Moisturizers
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
ASSURED Instant Hand Sanitizer Vitamin E and Aloe
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
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
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
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
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
blumen ADVANCED HAND SANITIZER
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
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
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
Auryxia (ferric citrate)
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class II · Moderate risk
Shine & Clean Hand Sanitizer gel
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.