Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use On...
FDA Recall #D-0643-2017 — Class I — February 3, 2017
Product Description
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
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@74, Exp 2/4/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated