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FDA Alerts

Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products. 12/1/2018 3:35:00 AM

Gemini Food Corporation has voluntarily recalled all Imperial Taste Fried Red Onions & Fried Garlic canisters as a precautionary measure because it?s missing an allergen statement and the ingredient panel does not include wheat. 11/29/2018 9:01:00 PM

ELM Pet Foods, Inc is issuing a voluntary recall of Elm Chicken and Chickpea Recipe dog food because the products could contain elevated levels of Vitamin D. 11/29/2018 7:00:00 PM

ANF, Inc. is issuing a voluntary recall of select products of ANF Pet Lamb and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D. 11/28/2018 10:23:00 PM

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of ?Kinkead? cheese made on 5-10-18, 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. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. 11/28/2018 9:06:00 PM

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds 11/28/2018 12:02:00 AM

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 11/27/2018 9:16:00 PM

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan?s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes. 11/27/2018 8:13:00 PM

Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve? Puppy, Sportsman?s Pride? Large Breed Puppy and Triumph? Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D. 11/27/2018 5:52:00 PM

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare? HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap. 11/26/2018 6:51:00 PM

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500? Series Flow Cytometers (FC 500), COULTER? EPICS? XL? and COULTER? EPICS? XL-MCL? Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA). 11/23/2018 5:46:00 PM

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex. 11/21/2018 7:39:00 PM

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC). 11/21/2018 3:32:00 AM

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States. 11/17/2018 2:59:00 PM

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap?n Crunch?s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health. 11/17/2018 3:46:00 AM

Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. 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. 11/17/2018 2:03:00 AM

Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes. 11/17/2018 1:37:00 AM

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. 11/13/2018 8:13:00 PM

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). 11/9/2018 2:06:00 PM

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. 11/8/2018 12:02:00 AM

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. 11/7/2018 7:40:00 PM

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. 11/6/2018 12:26:00 AM

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. 11/3/2018 1:03:00 AM

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. 11/2/2018 8:42:00 PM

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) 10/30/2018 4:21:00 PM

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