Clinimix E 4 — Class II drug recall D-0301-2015
Terminated recall by Baxter Healthcare Corp., reported 2014-12-24, distributed nationwide. Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
| Recall number | D-0301-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-11-25 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 7,220 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-0202, 00338-0202-01, 00338-0202-06, 00338-0206, 00338-0206-01, 00338-0206-04, 00338-0210, 00338-0210-01, 00338-0210-06, 00338-0214, 00338-0214-01, 00338-0214-04, 00338-1113, 00338-1113-04, 00338-1115, 00338-1115-04, 00338-1123, 00338-1123-04, 00338-1125, 00338-1125-04, 00338-1142, 00338-1142-03, 00338-1144, 00338-1144-03, 00338-1145 and 32 more |
| Lot numbers | P311357 |
| Expiration dates | 2015-12-31 |
Product
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Reason for recall
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
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-0301-2015. 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.