DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used wi...
FDA Recall #D-0286-2023 — Class II — December 27, 2022
Product Description
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
Reason for Recall
Lack of sterility assurance
Recalling Firm
Sentara Infusion Services — Chesapeake, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
17 bags
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use Date: December 25-30, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated