DrugNews' Weekly Recap of FDA Recalls & Warnings

Monday, July 11, 2016
FDA Recalls

This past week, the U.S. Food and Drug Administration took action by issuing recalls or warnings on six products it deemed had unknown dangers to consumers. Three of these were food products and three were prescription drugs.

Here, DrugNews recaps the various warnings and recalls you should know:


Food Recalls

A recall was issued for the Krusteaz Blueberry Pancake Mix from Continental Mills manufactured between April and June of 2016 due to the possible presence of E. coli O121 contamination in the blueberry nuggets.

The 48oz. Deluxe S'mores Ice Cream sold in Kroger stores is being recalled due to the presence of an undisclosed peanut allergen.

Finally, Hearn Kirkwood is recalling certain batches of its Evie’s Cheddar Potato Salad sold in the Bellevue, WA locations of Amazon Fresh between April 8th and June 13th due to possible Listeria monocytogenes contamination of frozen peas used in the product.

Listeria is an infection that can cause severe symptoms or even death in young children or the elderly. It may also cause miscarriage or fetal death in pregnant women. However, it is usually only associated with short-term headache, fever, diarrhea, stiffness, nausea and abdominal pain.


Drug Warnings

A new box warning was added to the uric acid treatment Elitek due to post-approval reports that the drug may be linked to serious and fatal allergic reactions such as anaphylaxis.

Patients should speak with their doctor about their risks, and stop use immediately if a hypersensitivity reaction happens.

The seizure and spasm medication Sabril was given an additional label warning due to heightened risks that it may cause retina damage and permanent loss of vision in both eyes, including tunnel vision.

Lastly, the FDA added label warnings to the extended release diabetes drug Xigduo XR, based on reports that it may be linked to lactic acidosis. Lactic acidosis caused by metformin drugs has bee known to result in hospitalization or death.

For more on drug and product warnings and recalls, follow DrugNews.net.



Recall Info

Other drugs and devices in the news:

Thursday, May 16, 2019
Serious Health Warnings Added to Gout Drug Uloric

For the second time in just over a year, the FDA has added serious health warnings for patients that may be prescribed the gout medication Uloric, also known by its generic name febuxostat.

Thursday, January 17, 2019
3M Earplugs
3M Knowingly Harms Troops: Supplies Defective Combat Earplugs

Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.

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