Class I - Dangerous
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level