Delflex FDA Alerts

Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

Includes:

• 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container
• 70% Dextrose Injection (2000 mL) USP

ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. See the Press Release for affected lot numbers.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage 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: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes and may also be used as a priming solution in hemodialysis procedures. 70% Dextrose Injection (2000 mL) USP is indicated as a source of calories and water for hydration.

RECOMMENDATION: Baxter is directing customers not to use the product from the recalled lots. Recalled 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 a.m. and 6 p.m., Central Time. Unaffected lots of product are available for replacement. This recall is not expected to affect current supply and product remains available for current customers.

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[12/18/2015 - Press Release - Baxter]

Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution

[Posted 12/27/2013] 

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[12/26/2013 -Press Release - Baxter]

Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination

ISSUE: FDA and Hospira announced it is initiating a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted in the solution.

When a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If contaminated solution is used on a patient, critical patient harm may result.  Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening.  Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.

BACKGROUND: The impacted product is Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL; NDC #0409-7929-09 Batch# 12-160-JT* Expiration Date 1DEC2013. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. This recall is being conducted as a precautionary measure.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-7688, between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

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.accessdata.fda.gov/scripts/medwatch/index.cfm

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

[10/05/2012 - Recall - Firm Press Release]