Just Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
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Labeling Not Elsewhere Classified: Product labeled to contain methanol
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Subpotent drug
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Failed Tablet/Capsule Specification; complaint of bulging tablet
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
Lack of Assurance of Sterility
CGMP Deviation: Potential contamination with undeclared methanol.
cGMP Deviations.
cGMP Deviations.
cGMP Deviations.
cGMP Deviations.
Subpotent drug: Out of specification for assay at the 15-month test interval.
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.