CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, us...

FDA Recall #D-0282-2023 — Class II — December 27, 2022

Recall #D-0282-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or 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

bags

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 25-30, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated