Drugs Recalls

SubPotent: Out of Specification

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.

SubPotent: Out of Specification

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.

Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.

Defective container: possibility for lack of seal integrity.

Lack of Assurance of Sterility

SubPotent: Out of Specification

SubPotent: Out of Specification

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

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Failed Tablet/Capsule Specification: Some tablets are shaved