10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthca...
FDA Recall #D-0425-2017 — Class II — December 6, 2016
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,528 eaches
Distribution
US
Code Information
Lot #: P333617, Exp 4/30/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated