FDA Drug Class II — Moderate

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

Hazard

Lack of assurance of sterility: Product bags leaking at seam.

Products

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. Litt
Brand
SCA Pharmaceuticals
UPC
LOT # 20170508@15, Use By: 06/22/17

Units Affected

70 bags