Clinimix E 5/20 sulfite-free — Class II drug recall D-0428-2015
Terminated recall by Baxter Healthcare Corp, reported 2015-04-08, distributed nationwide. Lack of Assurance of Sterility; increased complaints received for leaks
| Recall number | D-0428-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2015-03-31 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | SG |
| Quantity | 7,444 containers |
| 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 | P306365 |
| Expiration dates | 2015-08-31 |
Product
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Reason for recall
Lack of Assurance of Sterility; increased complaints received for leaks
Machine access
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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.