Safety Notification Issued on OmniPod Insulin Management System

Recent Recalls 

On November 2, 2015 (but not released until December 2, 2015) a voluntary Field Safety Notification was released by Insulet Corporation for 15 lots of the OmniPod, which were distributed in the United States and three lots distributed internationally. Since Novemeber 2, Insulet has been notifying its distributors and customers by email and phone calls.

So what exactly happened? There was a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in deployment of the needle mechanism. When this occurs, the needle will not be inserted and insulin delivery will not begin for those with diabetic conditions. This could cause hyperglycemia, which could result in diabetic ketoacidosis. 66 Medical Device Reports have been made requiring medical intervention; however, there have been no serious injuries or deaths reported in patients.

If you believe you have OmniPods from the affected lots, you should contact Insulet. You can contact them via telephone at 1-855-407-3729 any time. (1)

Lipo Escultura Recalled Due to Undeclared Sibutramine and Diclofenac

On December 3, 2015, Lipo Escultura Corporation recalled all Lipo Escultura capsules that have been found through FDA testing to contain two potentially harmful ingredients, sibutramine and diclofenac.

Why are sibutramine and diclofenac so dangerous? Sibutramine is an appetite suppressant that was removed from the market because of safety issues, which include substantially increasing blood pressure and pulse rate in patients. Diclofenac is a non-steroidal anti-inflammatory drug that could cause increased risk of cardiovascular events like heart attack and stroke, as well as serious gastrointestinal damage like bleeding, ulceration, and fatal perforation of the stomach and intestines. The recall was initiated after consumer illness was reported to the FDA and the product labeling was found to not include these harmful ingredients.

If you own this product, immediately discontinue use of it. If you have questions, you should contact Julio Tapia at 718-415-2611 Monday through Friday from 9 am to 5 pm EST. (2)

Nut Butter Spread Products Recalled Due to Possible Health Risk 

On December 2, 2015, JEM Raw Chocolate recalled its full line of all nut butter spreads within expiry because of the potential to be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weak immune systems. Symptoms can include vomiting, fever, abdominal pain, and even severe illnesses like arterial infections and arthritis.

So what products is part of the recall? It includes all products and sizes, packaged in glass jars, and sold under the brand name JEM Raw Organics. These include Cashew Cardamom, Cinnamon Red Maca, Hazelnut Raw Cacao, and more.

These products are being removed from retail shelves by distributors and retailers; however, it is noted that consumers do not have to return the product to the store where it was purchased. Consumers are urged to discard any product and its container, and then JEM Raw will work directly with consumers to replace the product. If you have any more questions, you can call 541-728-3844 Monday through Friday. (3)

Works Cited

1. http://www.fda.gov/Safety/Recalls/ucm475099.htm
2. http://www.fda.gov/Safety/Recalls/ucm475550.htm
3. http://www.fda.gov/Safety/Recalls/ucm475341.htm