All Recalls

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.

There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

The kit contains the wrong vial tray in the package.

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury