FDA Recall Brevibloc
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on April 12th, 2016 and classified as a Class II recall due to discoloration: presence of atypical yellow discoloration of the solution . This recall is currently terminated, and the associated recall number is recall number is D-0852-2016. It pertains to Brevibloc identified by 10019-075 as of 03-20-2017 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0852-2016 | 04-12-2016 | 05-18-2016 | 11,630 babs | 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 | Discoloration: presence of atypical yellow discoloration of the solution . | Terminated |
| D-1413-2014 | 06-16-2014 | 07-09-2014 | 20,810 containers | 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. | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
