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Undeclared egg.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Misbranding of the ingredient the firm sells ( Passionflower Herb Extract )
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
cGMP Deviations