Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceutica...

FDA Recall #D-0639-2017 — Class I — February 3, 2017

Recall #D-0639-2017 Date: February 3, 2017 Classification: Class I Status: Terminated

Product Description

Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40

Reason for Recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Recalling Firm

SCA Pharmaceuticals — Little Rock, AR

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

50 bags

Distribution

U.S. Nationwide

Code Information

Lot: 20161221@70, Exp 02/04/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated