FDA-Drug2023-02-22Class II

DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services
Hazard

Lack of sterility assurance

Sold states
Dispensed to Patients Nationwide.
Affected count
17 bags
Manufactured in
535 Independence Pkwy Ste 300, N/A, Chesapeake, VA, United States
Products
DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2023

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