PlainRecalls
FDA Drug Moderate Class II Terminated

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

Reported: December 24, 2014 Initiated: November 25, 2014 #D-0301-2015

Product Description

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

Reason for Recall

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
7,220 bags
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04. Recalled by Baxter Healthcare Corp.. Units affected: 7,220 bags.
Why was this product recalled?
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Which agency issued this recall?
This recall was issued by the FDA Drug on December 24, 2014. Severity: Moderate. Recall number: D-0301-2015.