Brevibloc Premixed Injection — Class II drug recall D-1413-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-07-09, distributed nationwide. Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles
| Recall number | D-1413-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-06-16 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2017-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 20,810 containers |
| Reason classes | specification failure |
| NDC | 10019-0055, 10019-0055-61, 10019-0075, 10019-0075-87, 10019-0115, 10019-0115-01, 10019-0115-39 |
| Lot numbers | 01/16, C926923 |
Product
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Reason for recall
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
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-1413-2014. 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.