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Lack of Assurance of Sterility
Failed Dissolution Specifications
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Failed Stability Specification; Out of specification for Osmolarity
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.