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CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Potential cross contact with sesame.
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Presence of foreign material in food (plastic)
CGMP Deviations: Out of specification for residual solvents.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Undeclared allergen milk (whey) and undeclared lard
Glass contamination
Failed Stability Specifications: Out of specification for blend uniformity.
CGMP Deviations: potential presence of Burkholderia cepacia complex
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Possible listeria monocytogenes contamination
cGMP Deviations: Products were stored outside the drug label specifications.
Elevated levels of vitamin D3
undeclared walnut
Undeclared sulfites