All Recalls

potential metal fragments in product

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Defective Delivery System: customer complaints exceeded respective action limits.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Lack of assurance of sterility.

Lack of assurance of sterility.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.