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Subpotent
Foreign Object - Wood. The firm was notified by their supplier that the product may contain pieces of wood.
CGMP Deviations
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Firm's product, Creamy Butter Sauce, was manufactured with recalled ingredient (Cilantro) which contained small wood like pieces.
Potential contamination with foreign material (wood)
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Undeclared allergen (soy)
Undeclared Allergen (walnuts), was not on outer packaging but was on the inner packaging of product.
Undeclared Wheat and Soy
Potential contamination with foreign objects.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit