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Lack of assurance of sterility.
Lack of Assurance of Sterility: Malformed crimped collar seal
Subpotent Drug: Out of specification results for low potency was obtained.
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
CGMP deviations.
Dietary supplement may contain metal
A small number of cartons may contain food grade sanitizer
CGMP deviation: product outside labeled storage temperature requirements.
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Colostrum is declared but label does not declare milk.
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.