Healthcare Company Recalls Multiple Injectables: See Affected Drugs

Multiple injectable drugs from the same company have been recalled over potential fiberglass and metal contamination.

Baxter International Inc. voluntarily recalled two injections used to provide nutrition, water and electrolytes to patients. A third injectable, an anticoagulant used to slow blood clotting, was also recalled, but it affected only one patient.

The medication solutions could be contaminated with fiberglass or stainless steel particles, according to Food and Drug Administration notices published Aug. 25 and Aug. 26. Injecting these medications could result in blockages, clotting issues and tissue or organ injury, according to the notices.

The supplies were sent mostly to health care facilities and distributors in several states, but they could also be in at-home health care settings. USA TODAY contacted Baxter for comment Aug. 27 but had not received a response.

Which Medications Were Recalled?

Recalled Baxter medications include:

• 70% Dextrose Injection, USP, in a 2,000-mL Viaflex plastic container.
• 0.9% Sodium Chloride Injection, USP, in a 500-mL Viaflex plastic container.
• Anticoagulant Sodium Citrate Solution, USP, in a 250-mL Viaflex plastic container. The FDA said it was distributed to only one customer.

Nutrition Injection Recalled for Metal Fragments

70% Dextrose Injection is a liquid solution mixed with other fluids to provide calories and nutrition through a person’s veins when the person cannot consume enough nutrients by mouth or through a feeding tube.

One lot was recalled because it may contain stainless steel fragments. Injecting a solution contaminated with metal particles can cause blockage or clotting in blood vessels, potentially leading to blood clots in the lungs or disruption of blood flow to vital organs, according to the FDA. Less severe effects can include allergic reactions, vein irritation or inflammation.

The impacted product was distributed to health care providers and distributors in Alabama, Georgia and Tennessee between July 25 and July 28. No adverse reactions had been reported.

Water and Electrolyte Injection Recalled for Fiberglass

0.9% Sodium Chloride Injection is often used as a source of water and electrolytes when a person cannot get what they need by eating, drinking or through other medical treatments. It can also be used during procedures such as blood transfusions and hemodialysis, which helps the body filter waste when the kidneys cannot.

Two lots were recalled because they may contain fiberglass. If injected, the particles could cause blood clots, blockages, blood-supply problems and organ damage, as well as inflammation and irritation, according to the FDA.

The impacted product was distributed between July 31 and Aug. 3 to health care providers and distributors in Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia. No adverse reactions had been reported.

How to Check Your Medical Supplies

The dextrose injections were sent to health care providers and distributors from July 25 to July 28 in Alabama, Georgia and Tennessee. The affected drugs could be in home health care settings and in the hands of consumers providing or receiving at-home care, according to the FDA notice.

The injections are packaged in a 2,000-mL Viaflex plastic container, with six units per case. The affected dextrose product can be identified by these details:

Product CodeProduct DescriptionLot NumberExpiration DateNDC Number
2B0296H70% Dextrose Injection, USP, 2,000 mL Viaflex plastic container; pharmacy bulk package, not for direct infusionY495066July 31, 20270338-0719-06

The sodium chloride injections were sent to the states listed above between July 31 and Aug. 3. They are packaged in 500-mL Viaflex plastic containers, with 24 units per case. The affected sodium chloride products can be identified by these details:

Product CodeProduct DescriptionLot NumberExpiration DateNDC Number

2B1323Q0.9% Sodium Chloride Injection, USP, 500 mL Viaflex plastic containerY495523Oct. 31, 20270338-0049-03
——Y495523A——

Customers can identify the products by locating the lot number and expiration date on the individual product and shipping carton.

What to Do With Recalled Medications

If you have any of the recalled injections, do not use them. Return the recalled products to the facility from which they came. Contact the health care distributor or facility that provided the injections to ask about its protocol for returning or disposing of them.

Consumers with questions can contact the Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday. If you have experienced problems that may be related to taking or using these drugs, contact your physician or health care provider. Baxter is also contacting customers by email with instructions for identifying and returning the affected products.

To report adverse reactions to the FDA, consumers can use the FDA’s MedWatch Adverse Event Reporting program online, by mail or by fax. To submit a report online, visit fda.gov/medwatch/report.htm.

For mail or fax, download the form at fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178.

This article is for general information and does not replace advice from your physician or health care provider.