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Lack of assurance of sterility: bags have the potential to leak..
Lack of Assurance of Sterility: leaking bags
L. mono contamination
During an FDA Inspection it was discovered swollen and leaking cans.
Subpotent Drug
cGMP Diviations
May contain foreign material (plastic)
Undeclared Allergens: Yellow # 5
Undeclared Allergen: Yellow #5
Potential growth of Staphylococcus aureus
Foreign material (metal) in donuts
Due to elevated levels of lead in ground cinnamon
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
CGMP Deviations
Product has been recalled because it may exceed FDA guidance levels for leachable lead.
Undeclared pineapple, sugar, modified corn starch, natural flavors, phosphoric acid
During an internal investigation the firm discovered that product labeled as Zero Sugar contains full sugar product.