Complete FDA and NHTSA recall records dated in July 2019.
These records include useful source details for the selected month.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
cGMP Deviations: Products may have microbial contamination.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
BMW of North America, LLC (BMW) is recalling certain 2018-2019 X3 sDrive30i, xDrive30i and M40i and 2019 X4 xDrive30i and M40i vehicles. The front seatback frames may have been improperly…
Mazda North American Operations (Mazda) is recalling certain 2019 Mazda3 vehicles equipped with manual dimming mirrors. The adhesive between the interior rearview mirror and the housing may…
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 vehicles. The instrument cluster may not properly illuminate driver warnings. As such, these vehicles fails to conform with the…
The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily…
Potential for failed stability antimicrobial effectiveness testing.
WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds.
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label…
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences,…
Lack of an adequate sterilization validation.
The products do not have sufficient data to support the labeled shelf life of 10 years.
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.
