NDC 0338-1130
Premasol - sulfite-free (Amino Acid) 19 ingredients injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Dec 6, 2016 · Class II · Baxter Healthcare Corporation
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: Lot #: P333617, Exp 4/30/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methio: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 19 ingredients
- Approval
- ANDA ANDA075880
- On the market since
- Jun 19, 2003
- Package NDCs
0338-1130-030338-1130-040338-1130-06- Official label
- DailyMed (National Library of Medicine), updated Aug 4, 2022
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