Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Service...

FDA Recall #D-0273-2023 — Class II — December 27, 2022

Recall #D-0273-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, 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

7 bags

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use date: December 28 - December 30, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated