10% Premasol sulfite-free — Class II drug recall D-0425-2017
Terminated recall by Baxter Healthcare Corporation, reported 2017-01-18. Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result
| Recall number | D-0425-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2016-12-06 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2018-03-26 |
| Quantity | 3,528 eaches |
| NDC | 00338-1130, 00338-1130-03, 00338-1130-04, 00338-1130-06, 00338-1131, 00338-1131-03 |
| Lot numbers | P333617 |
| Expiration dates | 2017-04-30 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0425-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.