Class II · Moderate risk Terminated
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055…
Reason cGMP Deviations
Is Alcohol recalled?
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.
Class II · Moderate risk Terminated
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation…
Reason cGMP Deviations
Class II · Moderate risk Completed
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC…
Reason CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Class II · Moderate risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC…
Reason CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to…
Class I · High risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC…
Reason Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class II · Moderate risk Ongoing
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c)…
Reason CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Class I · High risk Terminated
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By…
Reason Chemical Contamination: product found to contain benzene
Class II · Moderate risk Terminated
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity…
Reason GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk Terminated
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No…
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Terminated
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water…
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540…
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC…
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Terminated
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Ongoing
READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999747 READY IN…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline…
Reason Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and…
Class II · Moderate risk Ongoing
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ…
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk Terminated
TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk Terminated
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a)…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
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