PlainRecalls
FDA Drug Moderate Class II Terminated

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

Reported: April 3, 2024 Initiated: November 9, 2023 #D-0425-2024

Product Description

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
368 bags
Distribution
Nationwide in the USA
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359. Recalled by SCA Pharmaceuticals, LLC. Units affected: 368 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on April 3, 2024. Severity: Moderate. Recall number: D-0425-2024.