Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmac...
FDA Recall #D-0640-2017 — Class I — February 3, 2017
Product Description
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
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
386 bags
Distribution
U.S. Nationwide
Code Information
Lot: 20161228@65, Exp 02/26/2017; Lot: 20161214@76, Exp 02/12/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated