FDA Drug recall D-1413-2014
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, p…
- FDA Drug
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, p… by Baxter Healthcare, citing presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1413-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-16 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Identifiers
| ndc | 10019-115-39 |
|---|---|
| ndc | 10019-115-01 |
| ndc | 10019-075-87 |
| ndc | 10019-055-61 |
| code_info | Lot #: C926923, Exp 01/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1413-2014%22
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