Prescription Drugs

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.

Subpotent

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

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 Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

Non-Sterility: firm's third party lab confirmed microbial contamination.

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.

Labeling: Not elsewhere classified: Mislabeling

Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.

Marketed without ANDA/NDA approval

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.

Defective container: possibility for lack of seal integrity.

Lack of Assurance of Sterility

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Correct Labeled Product Mispack

Lack of Assurance of Sterility