FDA-Drug2017-01-18Class II

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

Baxter Healthcare Corporation
Hazard

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Sold states
US
Affected count
3,528 eaches
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2017

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