Class I - Dangerous
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Aidarex Pharmaceuticals
Class I - Dangerous
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class I - Dangerous
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Class I - Dangerous
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class I - Dangerous
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg