Recalls That Should Be on Your Radar—Week of January 12, 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:

Fusion IV Pharmaceuticals Recalls All Sterile Drug Products Due to Lack of Sterility Assurance

Fusion IV Pharmaceuticals, also operating under the name AXIA Pharmaceutical, has issued a voluntary recall of all unused sterile drug products within expiry due to a lack of certainty around the sterility of the products. The recalled products have been found inconsistent with federal guidelines.

Use of a drug product that is not sterile can result in serious, life threatening infections. To date, FUSION IV Pharmaceuticals has not received reports of adverse events associated with the recalled products.

Read the recall statement.

Taro Pharmaceuticals Recalls Lamotrigine 100 mg Tablets Due to Cross Contamination

Taro Pharmaceuticals has issued a voluntary recall of 1 lot of Lamotrigine 100 mg tablets, lot # 331771 (expiring June 2021) in 100 count bottles. This lot of Lamotrigine was found to have been cross contaminated with a small amount of Enalapril Maleate.

Lamotrigine is indicated for epilepsy and bipolar disorder. Enalapril Maleate is indicated for hypertension and congestive heart failure. Long term use of Enalapril Maleate is associated with risks for young children and pregnant women. Particularly, there may be impact on birth defects in developing fetuses.

There have not been any adverse events reported in connection with this recall to date.

Read the recall statement.

Stryker Replaces Malfunctioning Keypads in Lifepak 15 Monitor/Defibrillator

Stryker has launched a voluntary field action on specific units of the Lifepak 15 defibrillator due to units which fail to deliver a shock after the “shock” button on the keypad is pressed. The problem is due oxidation which may form over time within the shock button.

The company is contacting customers with impacted devices to schedule maintenance, which will include replacement of the keypads.

Read the statement.

Cardinal Health Issues Alert on Lack of Sterility Assurance in Surgical Gowns and Packs

The medical device manufacturer Cardinal Health has alerted customers to potential quality issues affecting some level 3 surgical gowns and presource procedural packs that contain the gowns.

The FDA and Cardinal Health recommend that customers should discontinue use of affected gowns and procedural packs which contain these gowns because the company cannot provide assurance that the products are sterile.

The FDA is working to assess the cause and impact of the problem.

Read the statement.

Lipari Foods Expands Recall of Premo and Fresh Grab Sandwiches Due to Potential Listeria monocytogenes Contamination

Lipari foods has issued a voluntary recall expansion of additional Premo and Fresh Grab sandwiches due to potential contamination with Listeria monocytogenes.

Listeria monocytogenes can cause serious infections in those with compromised immune systems such as children or older adults.

The problem was discovered by JLM manufacturing during environmental sampling which returned a positive test result for Listeria monocytogenes. There have been no illnesses reported in relation to the products to date.

Read the recall statement.