D-1413-2014 Class II Terminated
FDA drug recall D-1413-2014 was initiated by Baxter Healthcare Corp. on Jun 16, 2014 and is designated Class II. Reason for recall: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. The recall status is terminated (terminated Apr 10, 2017). Affected quantity: 20,810 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 9, 2014
- Initiation Date
- Jun 16, 2014
- Termination Date
- Apr 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,810 containers
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: C926923, Exp 01/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1413-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026