CGMP Deviations: Failure to properly investigate failed microbial testing.
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CGMP Deviations: Failure to properly investigate failed microbial testing.
Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02
Best Brands Consumer Products
Chemical Contamination; FDA analysis found product to contain methanol
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
Best Brands Consumer Products
Chemical Contamination; FDA analysis found product to contain benzene
Chemical contamination: presence of benzene
Incorrect/Undeclared Excipient: Product contains alcohol
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
Unilever United States
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
artnaturals Hand Sanitizer
VIRGIN SCENT
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.
Revive Personal Products Company
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Lack of sterility assurance.
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Tennessee Technical Coatings
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Tennessee Technical Coatings
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.