458 FDA recalls mention Alcohol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alcohol.
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Reason Chemical Contamination; FDA analysis found product to contain benzene
Reason Chemical Contamination; FDA analysis found product to contain methanol
Reason CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Reason Sub Potent
Reason Sub Potent
Reason Super Potent
Reason Sub Potent
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot…
Reason Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product…
Reason Labeling - product contains undeclared ethyl alcohol
Reason Labeling - product contains undeclared ethyl alcohol
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Reason Defective Container: Customer complaints for leaking bottles and dispensing issues.
Reason CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Reason Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
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