December 2016 FDA Recall Premasol - Sulfite-free (amino Acid) by Baxter Healthcare Corporation (D-0425-2017 - Discoloration)

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on December 6, 2016 for the product Premasol - Sulfite-free (amino Acid). The FDA reported the reason for recall as discoloration. The product was distributed in US and the recall is currently terminated.

Recall Number: D-0425-2017

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.
Initiated
12-06-2016
Reported
01-18-2017
Quantity
3,528 eaches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75835
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-26-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : P333617, Exp 4/30/17

Affected Packages Involved in this Recall

0338-1130-03 Premasol - Sulfite-free (amino Acid)
0338-1130-04 Premasol - Sulfite-free (amino Acid)
0338-1130-06 Premasol - Sulfite-free (amino Acid)
0338-1131-03 Premasol - Sulfite-free (amino Acid)