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Undeclared milk
Undeclared Milk. During an FDA investigation the manufacturer was notified that the label does not list the allergen milk in the ingredient statement.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
CGMP Deviations
Presence of cathine in product
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Failed Dissolution Specifications:
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Presence of Foreign Tablets/Capsules
Product may contain spoilage organisms.
Potential for premature product spoilage during shelf life.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Products may contain foreign objects (plastic).
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.