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CGMP Deviations: Presence of NDMA impurity detected in product.
The product contains undeclared sulfites.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.