CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Lack of sterility assurance
💊 Drugs • 1,855 recalls
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Short Fill
Short Fill
CGMP Deviations:
CGMP Deviations:
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.