DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pu...
FDA Recall #D-0287-2023 — Class II — December 27, 2022
Product Description
DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. 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 24-31, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated