FDAFDA · Food and drugs·Recall number D-0425-2017
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
Published January 18, 2017 · Recall initiated: December 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Brand
- PREMASOL - SULFITE-FREE (AMINO ACID)
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US
- Lot
- Lot #: P333617, Exp 4/30/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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