Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0338-1130-06 recalled?

Premasol - sulfite-free (Amino Acid) · 2000 mL in 1 BAG (0338-1130-06)

Yes — this exact package was recalled

1 FDA recall names the code 0338-1130-06 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-Acetyl-Tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride
Strength
LEUCINE 1.4 g/100mL; LYSINE ACETATE .82 g/100mL; ISOLEUCINE…
Form
Injection, Solution · Intravenous
Labeler
Baxter Healthcare Company
Type
Human Prescription Drug
Product code
0338-1130

Recalls naming this package

Class II · Moderate risk

10% Premasol sulfite-free

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.

Terminated Failed specification Baxter Healthcare Corporation NDC 0338-1130-06 D-0425-2017

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler