Class I - Dangerous
Failed Dissolution Specifications
Amneal Pharmaceuticals of New York
Superpotent Drug: Due to overfilling of drug powder
Failed dissolution specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Failed dissolution specifications.
Class I - Dangerous
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class I - Dangerous
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Failed dissolution specifications; 18 month CRT