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
FDA Drug Recalls
17,898 recalls, newest first
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.
Class II · Moderate risk Terminated
Auryxia
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class II · Moderate risk Terminated
Shine & Clean Hand Sanitizer gel
Reason 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.
Class I · High risk Terminated
Daptomycin for Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level