Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Elevated Osmophilic Yeast Count
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Failed Impurity/Degradation Specifications
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Due to finished goods incorrectly packaged and labeled.
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Lack of Sterility Assurance
cGMP Deviations: Out of specification results for micro in hand soap products.