92,900 total recalls in our database
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications
EnShiShiXiangNiShangMaoYouXianGongSi
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Pro-Med Instruments Gmbh
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Beckman Coulter Ireland
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Potential for breach of Tyvek seals.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Potential for breach of Tyvek seals.
Ortho-Clinical Diagnostics
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
BioFire Diagnostics
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Potential for breach of Tyvek seals.
Maquet Cardiopulmonary Ag
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.