PlainRecalls
FDA Drug Moderate Class II Terminated

ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.

Reported: August 2, 2017 Initiated: July 14, 2017 #D-1001-2017

Product Description

ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.

Reason for Recall

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

Details

Recalling Firm
SCA Pharmaceuticals
Units Affected
108 bags
Distribution
Nationwide in the USA
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.. Recalled by SCA Pharmaceuticals. Units affected: 108 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 2, 2017. Severity: Moderate. Recall number: D-1001-2017.