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Potential contamination with Salmonella
Presence of particulate matter: glass
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
CGMP Deviations and Presence of Particulate Matter: Glass
CGMP Deviations: Out of specification for dissolution
Potential Salmonella contamination.
Product is recalled due to potential mold growth contamination.
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Undeclared Walnut
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Allergen (sesame seeds) declared in the ingredient statement but missing from the "Contains" statement
Undeclared allergen - coconut
CGMP deviations