CLINIMIX E 5/15 sulfite-free — Class I drug recall D-0864-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-06-01, distributed nationwide. Presence of Particulate Matter: identified as dried skin.
| Recall number | D-0864-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-01-21 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 7,436 bags |
| Reason classes | specification failure |
| 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 | P333930 |
| Expiration dates | 2017-05-31 |
Product
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Reason for recall
Presence of Particulate Matter: identified as dried skin.
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-0864-2016. 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.