95,083 total recalls in our database
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
CGMP Deviations
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Baxter Healthcare
Product was distributed in the United States without proper regulatory approval.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Siemens Medical Solutions USA
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).