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Undeclared Yellow #5, Yellow #6, and Red #40
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Finished product contains kratom (an unapproved food additive) and pH is over 5.0. The process authority letter classified product as acidified and pH cannot exceed 3.30.
foreign material - plastic
A frozen/ refrigerated food trailer holding various types and brands of frozen/ refrigerated foods were temperature abused.
Product contains undeclared macadamia nuts.
Undeclared Sesame
May contain generic E. coli
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.