Drug recall D-0425-2017

Class II Terminated reported Jan 18, 2017

Product

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.

Lots and codes

Lot #: P333617, Exp 4/30/17

Recall details

Recalling firm
Baxter Healthcare Corporation, Deerfield, IL
Quantity
3,528 eaches
Distribution
US
Type
Voluntary: Firm initiated
Recall initiated
December 6, 2016
Terminated
March 26, 2018

Related products