CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Compounded Drugs
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Lack of Assurance of Sterility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent Drug
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
Cascade Kelly Holdings
CGMP Deviations: Does not meet monograph for denaturant.
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
Cascade Kelly Holdings
CGMP Deviations: Does not meet monograph for denaturant.
SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
Scentsational Soaps & Candles
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
Scentsational Soaps & Candles
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.