FDA Alerts & Recalls ~~ Dec 2013


FDA (trade union)
12/29/2013 02:47 PM EST
ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837, is recalling herring fillet in oil (FOSFOREL, ATLANTIKA) 200 grams in plastic packaging due to Listeria contamination.

Giant Eagle Issues Allergy Alert On Undeclared Peanut Allergen In Candy Place Chocolate Santas

12/28/2013 05:54 PM EST
Candy Place Chocolate Santas packages were voluntarily recalled by Giant Eagle due to an undeclared peanut allergen. While the individual peanut butter filled candies reference “peanut butter�, peanuts are not listed as an ingredient on the primary package label, creating the potential for a serious or life-threatening allergic reaction if consumed by those with a peanut allergy. The product is safe for consumption by those who do not have a peanut allergy

Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

12/26/2013 09:38 PM EST
Baxter International Inc. announced today it has initiated a voluntary recall to the hospital/user level of one lot of 5 percent Dextrose Injection, USP and four lots of 0.9 percent Sodium Chloride Injection, USP due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter

12/23/2013 03:45 PM EST
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.
12/20/2013 04:08 PM EST
Concertos in Chocolate of Boulder, Colorado is recalling 450 solid milk chocolate Santas. Because of possible mislabeling it may contain undeclared milk products.
12/21/2013 10:42 AM EST
Spokane Produce, Inc., of Spokane Washington is recalling approximately 59 lbs of Victor’s Sesame Hummus due to concerns about possible Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
12/13/2013 09:59 PM EST
December 13, 2013 – Cheshire, Conn., – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles.
12/16/2013 03:03 PM EST
Megabusiness LLC of Danbury, CT is recalling Del Campo Papa seca / DRY POTATO 24×14 oz. because they contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.
12/16/2013 04:47 PM EST
Bee International, Inc. of Chula Vista, CA is recalling its 2oz. packages of candy “Sweet Spots” because they may contain undeclared egg protein. People who have allergies to egg may run the risk of serious or life-threatening allergic reaction if they consume this product.
12/16/2013 12:46 PM EST
Stone Independent Research, Inc. of Syracuse, NY is recalling 15,657 units of EnhanceRx, a dietary supplement, because it contains undeclared milk (whey protein). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
12/16/2013 12:43 PM EST
Stone Independent Research, Inc. of Syracuse, NY is recalling 1,040 units of Zanocap Scientific Weight Loss 500 mg capsules because it contains undeclared milk (whey protein). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume the affected product.
12/13/2013 03:35 PM EST
ee International, Inc. of Chula Vista, CA is recalling its 2oz. packages of candy “Sweet Spots” because they may contain undeclared egg protein. People who have allergies to egg may run the risk of serious or life-threatening allergic reaction if they consume this product.
12/16/2013 12:50 PM EST
Blooming Import Inc at 45 Bowne Street, Brooklyn, NY 11231 is recalling Farmer Brand Dried Lily Flowers because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
12/12/2013 02:18 PM EST
Blooming Import Inc at 45 Bowne Street, Brooklyn, NY 11231 is recalling Golden Lion Brand Dried Ziziphus Jujuba Mill (Dried Dates) because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Nipple Aspirate Test is No Substitute for Mammogram

12-12-13 3:46 pm

Some companies are marketing a new test, the “nipple aspirate test,” as the latest and greatest tool in early breast cancer screening.

But FDA warns that the nipple aspirate test is no substitute for a mammogram.
Read the Consumer Update to find out why.

12/12/2013 09:43 AM EST
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is recalling specific lots of ORGANIC TRADITIONS DARK CHOCOLATE HAZELNUTS, ORGANIC TRADITIONS DARK CHOCOLATE HAZELNUTS WITH CHILI, ORGANIC TRADITIONS DARK CHOCOLATE ALMONDS, and ORGANIC TRADITIONS DARK CHOCOLATE ALMONDS WITH CHILI because they were found to contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
12/12/2013 12:16 PM EST
Whole Foods Market Mid-Atlantic Region is recalling an organic creamy spinach dip because it contains eggs, an undeclared allergen.
12/03/2013 10:28 PM EST
Cargill‘s animal nutrition business today announced a voluntary recall of two of its Nutrena NatureWise poultry feeds due to incorrect levels of calcium. The affected products were manufactured at Cargill’s facilities in Flora, Ill., Oklahoma City, Okla., Abilene, Texas, and Mineola, Texas, between May 1, 2013 and Nov. 21, 2013.

Huxtable’s Kitchen Issues Voluntary Allergy Alert on Undeclared Allergens in Butternut Squash & Creamed Spinach Gratin

12/02/2013 05:15 PM EST
Huxtable’s Kitchen Inc. of Vernon, California is voluntarily recalling one specific lot of Trader Joe’s Butternut Squash & Creamed Spinach Gratin (SKU 96541) sold in the refrigerated section with “Use By 12/13/13” date, because it may not list wheat and egg in the ingredients. People who have an allergy or severe sensitivity to wheat and egg run the risk of serious or life-threatening allergic reaction if they consume this product.