Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences and should not be used. The lots being recalled were distributed to customers and distributors in the United States and Bermuda. Read the story for complete information.
Baxter International Inc. announced on April 9th that it is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.
Consumer Contact: 888-229-0001
While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter.
Products affected by this recall are listed in the following table:
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| Product Code | NDC Number | Product Name | Lot Number | Manufacturing Date | Expiration Date |
|---|---|---|---|---|---|
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C965038 | 01/20/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C965293 | 1/22/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C963785 | 01/09/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C963884 | 01/10/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C963660 | 01/08/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C964320 | 01/14/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C964486 | 01/15/2015 | 07/31/2016 |
| 2B1322Q | 0338-0049-02 | 0.9% Sodium Chloride Injection, USP (250mL) | C964890 | 01/19/2015 | 07/31/2016 |
| 2B0162Q | 0338-0023-02 | 10% Dextrose Injection, USP (250mL) | C965558 | 01/24/2015 | 07/31/2016 |
| 2B0162Q | 0338-0023-02 | 10% Dextrose Injection, USP (250mL) | C963520 | 01/07/2015 | 07/31/2016 |
| 2B0062Q | 0338-0017-02 | 5% Dextrose Injection, USP (250mL) | C963413 | 01/06/2015 | 07/31/2016 |
| 2B0062Q | 0338-0017-02 | 5% Dextrose Injection, USP (250mL) | C963413A | 01/06/2015 | 07/31/2016 |
| 2B2322Q | 0338-0117-02 | Lactated Ringer’s Injection, USP (250mL) | C964619 | 01/16/2015 | 07/31/2016 |
| 2B2322Q | 0338-0117-02 | Lactated Ringer’s Injection, USP (250mL) | C964056 | 01/12/2015 | 07/31/2016 |
| 2B2322Q | 0338-0117-02 | Lactated Ringer’s Injection, USP (250mL) | C964163 | 01/13/2015 | 07/31/2016 |
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Dextrose Injection, USP is indicated as a source of water and calories. Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes, or as an alkalinizing agent. The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015.
Baxter began the customer notification process on March 24, 2015. Customers have been directed not to use products from the recalled lots. Recalled products 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.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
