US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 6, 2016 (10 years ago)

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What 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

Recalling firm
Baxter Healthcare Corporation
NDC code
0338-1130-06
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0425-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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