FDA Drug recall D-0425-2017
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division,…
- FDA Drug
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division,… by Baxter Healthcare, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0425-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-06 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
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
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.
Identifiers
| ndc | 0338-1130-03 |
|---|---|
| ndc | 0338-1130-04 |
| ndc | 0338-1130-06 |
| ndc | 0338-1131-03 |
| code_info | Lot #: P333617, Exp 4/30/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0425-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.