Recall database
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Siemens Medical Solutions USA recalled 71 MAGNETOM Lumina MRI systems worldwide, including US and 50+ countries, due to ice blockage in the magnet venting system that could cause a helium leak during a quench.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Potential contamination with Listeria monocytogenes
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.