411 recalls · Class II, newest first
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Reason Failed Dissolution Specifications
Reason Subpotent Drug: reduced efficacy for epinephrine
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Reason Failed Dissolution Specifications: results below specifications
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the…
Reason Presence of particulate matter: glass
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Reason CGMP Deviations: Out of specification for dissolution
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.