Failed Impurities/Degradation Specifications:
Granules Pharmaceuticals
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class I - Dangerous
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level