PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 18, 2017 Initiated: December 6, 2016 #D-0425-2017

Product Description

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

Reason for Recall

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.

Details

Units Affected
3,528 eaches
Distribution
US
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Baxter Healthcare Corporation. Units affected: 3,528 eaches.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 18, 2017. Severity: Moderate. Recall number: D-0425-2017.