FDA-Drug2014-12-24Class II

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

Baxter Healthcare Corp.
Hazard

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

Sold states
Nationwide
Affected count
7,220 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2015

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