8046255 Canada Inc. DBA Viatrexx Viatrexx-Immunexx, 10 mL Sterile multi-dose vial recall — FDA D-0341-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Complete FDA and NHTSA recall records dated in November 2019.
These records include useful source details for the selected month.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
CGMP Deviations: Presence of NDMA impurity detected in product.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Subpotent Drug
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 trucks. These vehicles may have been built with a contaminated electric power steering (EPS) gear that may short circuit,…
General Motors LLC (GM) is recalling certain 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500, and 2020 Silverado 2500, Silverado 3500, Sierra 2500, and Sierra 3500 vehicles equipped…
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to…
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.