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Vitamin B6 level below percent declared on label
Subpotent Drug
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.