FDA recall D-0316-2023

Product

Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Reason for recall

Lack of sterility assurance

Distribution

Dispensed to Patients Nationwide.

Key facts

Status

Terminated

Initiation date

2022-12-27

Report date

2023-02-22

Termination date

2026-02-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0316-2023