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CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications
undeclared allergen ingredient Milk.
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Failed Content Uniformity Specifications
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lack of Assurance of Sterility
May contained undeclared almond
Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.
Product does not declare wheat in the allergen statement.