Food and Drug Administration--Recalls/Safety Alerts

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade (Wed, 14 Nov 2018 17:36:00 -0500) Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

The Pictsweet Company Recalls 8-ounce Steam’ables Asparagus Spears due to Potential for <em>Listeria Monocytogenes</em> (Tue, 13 Nov 2018 16:13:00 -0500) The Pictsweet Company has recalled 1,872 cases of Pictsweet Farms 8-ounce Steam’ables Asparagus Spears because they have the potential to be contaminated with Listeria monocytogenes.

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) (Tue, 13 Nov 2018 15:13:00 -0500) On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor Inc. is voluntarily taking this action.

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk (Mon, 12 Nov 2018 20:31:00 -0500) ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens (Fri, 09 Nov 2018 21:26:00 -0500) Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is issuing an immediate recall for bars with the following lot codes and best buy dates:

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D. (Fri, 09 Nov 2018 15:26:00 -0500) In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D (Fri, 09 Nov 2018 14:30:00 -0500) We regret to inform you that Natural Life® Chicken & Potato dry dog food has been confirmed to contain elevated levels of Vitamin D.

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API) (Fri, 09 Nov 2018 09:06:00 -0500) Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes (Thu, 08 Nov 2018 20:58:00 -0500) Ukrop’s Homestyle Foods is voluntarily recalling Baked Potatoes with Cheddar Cheese and Bacon (2 count), as the product is mislabeled Herb Roasted Potatoes (see photo attached).

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz. (Wed, 07 Nov 2018 19:02:00 -0500) Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions (Wed, 07 Nov 2018 14:40:00 -0500) Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes (Tue, 06 Nov 2018 22:14:00 -0500) Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella (Mon, 05 Nov 2018 19:26:00 -0500) Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D (Sat, 03 Nov 2018 11:13:00 -0400) Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D (Sat, 03 Nov 2018 11:13:00 -0400) Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions (Fri, 02 Nov 2018 21:03:00 -0400) Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn (Fri, 02 Nov 2018 17:13:00 -0400) Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk (Fri, 02 Nov 2018 16:42:00 -0400) Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API) (Tue, 30 Oct 2018 12:21:00 -0400) ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC)

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables (Tue, 30 Oct 2018 10:04:00 -0400) J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.