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Lack of Assurance of Sterility
CGMP Deviations
Undeclared soy
Subpotent Drug: Product does not contain SPF that is declared on the label.
Listeria monocytogenes
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
During an internal investigation, the firm noticed that the Retort Chart was malfunctioning. No data was recorded during the production run.