Failed Dissolution Specifications
Ascend Laboratories
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Superpotent drug
Failed Dissolution Specifications: low dissolution results
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Failed Dissolution Specifications
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Failed Dissolution Specifications
Out of specification (OOS) for Spectroscopic Identification test by IR.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Failed Dissolution Specification
Failed Dissolution Specification
Failed Dissolution Specification
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Failed Dissolution Specifications.
Failed impurities/degradation specifications
Failed Impurities/Degradation Specifications
Presence of Foreign Tablet/Capsule
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Failed Dissolution Specifications
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Presence of Foreign Substance; metal shard found in tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP