💊 Drugs • 11,927 recalls
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Presence of Particulate Matter.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
The Harvard Drug Group LLC
Failed Content Uniformity Specifications
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Private Label Partners
CGMP Deviations: Stability data does not support expiry date.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
SUN PHARMACEUTICAL INDUSTRIES
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Failed Dissolution Specifications
Right Value Drug Stores, LLC
Product Mix-up: Incorrect Product Formulation
Wells Pharma of Houston
Lack of assurance of sterility.
Failed Impurities/Degradation Specifications