Recalls That Should Be on Your Radar—Week of April 19, 2020

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

B. Braun Medical Inc. Issues Recall of Ceftazidime for Injection USP and Dextrose Injection USP Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

Braun Medical Inc. is voluntarily recalling 1 lot of 2g Ceftazidime for Injection USP and Dextrose for Injection USP in Duplex Container to the hospital/user level. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the 19 month stability interval.

Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels. To date there have been no complaints or reports of adverse reactions associated with this product lot.

Read the recall statement.

Fresenius Kabi Issues Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Read the recall statement.

Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753

Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.

The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.

Read the recall statement.