Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, ...

FDA Recall #D-0288-2023 — Class II — December 27, 2022

Recall #D-0288-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

Dextrose 10% 720ML, TPN, Rx only, use 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

1 bag

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 28, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated