VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, S...

FDA Recall #D-0323-2023 — Class II — December 27, 2022

Recall #D-0323-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with 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

18 bags

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 28-31, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated