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Cashews declared in ingredients statement but not in the contains statement.
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Short Fill
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
CGMP Deviations: potential for trace amounts of product carryover.
Raw material tested positive for Cronobacter sakazakii.
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Undeclared soy and egg
Foreign material (small glass particles)
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Almond listed on the ingredient label but is not in Contains statement.
Lack of Assurance of Sterility