Brevibloc Injection
FDA Recall NDC 10019-075
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Brevibloc (NDC 10019-075). A significant event, classified as Class II, was initiated on Apr 12, 2016 by Baxter Healthcare Company. The reported reason for this action was: "Discoloration: presence of atypical yellow discoloration of the solution ."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Discoloration: presence of atypical yellow discoloration of the solution .
Apr 12, 2016
May 18, 2016
11,630 babs
Recall Profile & Regulatory Data
Event ID
73812
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 20, 2017
Product Description
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Batch or Lot Expiration Information
Lot# C989954, Exp 9/17
Affected Packages Involved in this Recall
10019-115-39Product
10019-115-01Product
10019-075-87Product
10019-055-61Product
Class II Terminated
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Jun 16, 2014
Jul 09, 2014
20,810 containers
Recall Profile & Regulatory Data
Event ID
68577
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 10, 2017
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.
Batch or Lot Expiration Information
Lot# : C926923, Exp 01/16
Affected Packages Involved in this Recall
10019-115-39Product
10019-115-01Product
10019-075-87Product
10019-055-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
