Baxter International Inc. announced it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date.
Leaking containers could result in contamination of the solution. If not detected, this could lead to a bloodstream infection, worsened patient condition or other serious adverse health consequences. 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, damage to other organs such as the kidney or liver, or death. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The recalls affect the following products and lots:
- 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container
- Product code: 2B0043
- Lot number; P337857
- Expiration date: 7/31/2016
- NDC: 0338-0553-18
- 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container
- Product code: 2B0043
- Lot number: P328997
- Expiration date: 1/31/2016
- NDC: 0338-0553-18
- Metronidazole Injection, USP 500mg/100mL
- Product code: 2B3421
- Lot number: P339135
- Expiration date: 8/31/2017
- NDC: 0338-1055-48
- Clinimix E 5/15 (5% AA w/Electrolytes in 15% Dextrose w/Calcium)
- Product code: 2B7721
- Lot number: P333930
- Expiration date: 5/31/2017
- NDC: 0338-1123-04
Customers were notified via letter that they should not use 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 7:00 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 onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.