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Lack of Assurance of Sterility
Mislabeling: preservative free product labeled as preserved.
Sub-potent Drug
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Possible presence of foreign material (metal)
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Failed Dissolution Specifications; during stability testing
Subpotent: Low anti-factor IIa Potency.
Product contains undeclared soy lecithin and brown sugar syrup.
Contains undeclared ingredients including wheat and sesame
The ingredients statement declares Sesame but the Contains statement does not declare sesame. Sesame seeds are visible on product.
Due to over pressurization, can may fail/explode.