Class I - Dangerous
Subpotent Drug
⚗️
Compounded Drugs
💊 Drugs • 1,903 recalls
Class I - Dangerous
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Class I - Dangerous
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
SS Lemon Zest 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
Class I - Dangerous
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
SS Lavender & Herbs 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
Class I - Dangerous
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
SS Coconut Breeze 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
Class I - Dangerous
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I - Dangerous
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class I - Dangerous
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I - Dangerous
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I - Dangerous
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I - Dangerous
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I - Dangerous
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I - Dangerous
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.