ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 1...
FDA Recall #D-0877-2017 — Class II — May 18, 2017
Product Description
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
70 bags
Distribution
Nationwide in the USA
Code Information
LOT # 20170508@15, Use By: 06/22/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated