Prescription and over-the-counter medications
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Penicillin Cross Contamination
Penicillin Cross Contamination
Zions RX Formulations Services LLC
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Labeling; Missing label; ampoules are missing the immediate container label
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
American Health Packaging
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
American Health Packaging
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Viiv Healthcare Company
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Teva Pharmaceuticals USA
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Hill Dermaceuticals
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.