  |
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution
| Product Name | Product Code | NDC | Container Size | Lot # | Exp. |
|---|---|---|---|---|---|
| 5% Dextrose Injection, USP | 2B0089 | 0338-0017-38 | 100 mL | P285288 | Nov-13 |
| 0.9% Sodium Chloride Injection, USP | 2B1308 | 0338-0049-31 | 50 mL | P297283 | Aug-14 |
| 0.9% Sodium Chloride Injection, USP | 2B1302 | 0338-0049-18 | 100 mL | P292326 | Apr-14 |
| P293993 | May-14 | ||||
| 0.9% Sodium Chloride Injection, USP | 2B1309 | 0338-0049-38 | 100 mL | P293514 | Apr-14 |
AUDIENCE: Risk Manager, Pharmacy, Endocrinology, Nursing, Health Professional
ISSUE: Baxter International Inc. initiated a voluntary recall to the hospital/user level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP due to particulate matter found in the solutions.
Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
BACKGROUND: Dextrose Injection, USP is an intravenously administered injectable indicated as a source of water and calories. Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. These 50 mL and 100 mL containers are primarily used for admixture of medication and as priming solutions. Products affected by this recall were packaged in flexible plastic containers with 96 containers per carton.
Affected product was distributed to healthcare centers and distributors in Saudi Arabia, Singapore, United Arab Emirates, and the United States and Puerto Rico. The affected lots were distributed to customers between May 2012 and October 2013.
RECOMMENDATION: Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers that have product affected by this recall should stop use and arrange for return. Unaffected lot numbers can continue to be used according to the instructions for use. Affected product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
