FDA-Drug2023-02-22Class II

Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, 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
25 bags
Manufactured in
535 Independence Pkwy Ste 300, N/A, Chesapeake, VA, United States
Products
Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, 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-0300-2023

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