FDA warns of possible flea/tick med side-effects

The US Food and Drug Administration (FDA) today issued an alert to pet owners and veterinarians about possible neurological effects from use of certain flea and tick treatment products.

According to a spokesperson for FDA, as of July 31, 2018, the Center for Veterinary Medicine has received approximately 5400 reports of ataxia (difficulty standing/walking), muscle tremor, and/or seizures, in dogs and cats that received an isoxazoline product, out of millions of animals that have received one or more doses since these products came on the market.

Products containing isoxazoline products include: Bravecto, Credelio, Nexgard and Simparica and may be available in either a topical or a chew format, depending on the product.

Some of the neurological symptoms were seen during pre-market studies of these products, and the labels for some of the products already note the potential for neurologic events. Following a scientific evaluation of both the pre-market and post-market reports, FDA has determined that a label change is warranted across the category of isoxazoline products.

FDA urges pet owners to be on the alert for any neurologic effects after administering one of these products to their dogs or cats, and to report any adverse effects to the manufacturer or directly to FDA.

To report suspected adverse drug events for these products and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact the appropriate manufacturers at the following phone numbers:

Merck Animal Health (Bravecto): 800-224-5318
Elanco Animal Health (Credelio): 888-545-5973
Merial (Nexgard): 888-637-4251
Zoetis (Simparica): 888-963-8471

If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems.

Recalls and Alerts: September 16 – 18, 2018

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

Allergy Alert: Lidl US recalls all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections due to undeclared wheat. The affected product was sold at all Lidl US stores.

Canada

Food Safety Recall: Belleisle Foods Ltd. recalls Belleisle Farms Cole Slaw (227g; Product code 18SE25; UPC 0 33383 65260 3) due to Listeria monocytogenes contamination. The recalled product was distributed to consumers in New Brunswick, Newfoundland and Labrador, Nova Scotia, and Prince Edward Island.

Food Safety Recall: Future Seafoods Inc. recalls Future Seafoods Inc. Malpeque Oysters, Std. (25-count; Harvest/process date 09/10/18, Harvest location PE9B) due to Salmonella contamination. The recalled product was sold in Quebec and may have been distributed nationwide.

Europe

Allergy Alert (Netherlands): Kellogg’s recalls Kellogg’s Special K Milk Chocolate cereal (300g; French-language packaging only; Best before 06/03/2019 and 07/03/2019) due to undeclared soy, milk, wheat and barley.

Allergy Alert (Sweden) ICA recalls ICA’s Creamy Tortilla Bread Tenderloin tuna wrap (170g; Best before 2018-09-22) due to undeclared milk and chicken.

Food Safety Recall (Germany): Tillman´s Convenience GmbH recalls TK SKANDINAVIC’S Köttbullar (1000g; Best before 28.02.2019) due to foreign matter (pieces of blue plastic) contamination.

Food Safety Recall (Italy): CORSINO CORSINI Spa recalls Caffè 100% ARABICA MACINATO BIO (250g; Lot code 28/O4/2019 S) due to elevated ochratoxin levels.

Food Safety Recall (Ireland): Dr. Zak’s recalls Barn Farmed Liquid Egg White (970 ml; Lot #18180BN2A; Use by 29 December 2018) due to Salmonella contamination.

Food Safety Recall (UK): Dr Zak’s recalls Barn Farmed Liquid Egg White (970 ml; Lot #18180BN2A; Use by 29 December 2018) due to Salmonella contamination.

Australia and New Zealand

Food Safety Recall (Australia): G J Wholesale recalls various G J Wholesale Alcohol Products due to possible chemical contamination. Please refer to the recall notice for a complete list of affected products.

Recalls and Alerts: September 13 – 15, 2018

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United States

Allergy Alert: Sarap Asian Fusion recalls Asian Fusion Cookies (various flavors) due to undeclared wheat, milk and soy. Please refer to the recall notice for a complete list of affected products, which were distributed through online mail orders to: AE, AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IL, IN, JK, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, & WY.

Food Safety Recall: Bob Evans Farms, Inc. recalls approximately 42,246 pounds of pork sausage link products due to possible foreign matter (pieces of clear hard plastic) contamination. Please refer to the recall notice for a complete list of affected products, which were shipped to retail locations in Ind., Ill., Ky., Md., Mich., Mo., N.J., N.Y., N.C., Ohio, Pa., Va., and Wis.

Pet Food Safety Recall: Bravo Packing, Inc. recalls all Performance Dog raw, frozen pet food products due to potential Salmonella contamination. Please refer to the recall notice for additional details.

OTC Topical Product Safety Recall: BioLyte Laboratories recalls NeoRelief for Muscle Cramping and Restlessness Topical Gel (various sizes and lot numbers) due to potential microbial contamination. Please refer to the recall notice for a complete list of affected products.

Canada

Allergy Alert: Five Continents International Inc. recalls Lonely God brand Potato Rice Chips Barbecue Flavor (70g; All packages; UPC 6931958020229) due to undeclared milk. The recalled product was distributed to retailers in Ontario.

Food Safety Recall: Fourchette Vrignon (Montreal, QC) recalls Gourmet Go brand SAUCE À SPAGHETTI À LA VIANDE / Spaghetti sauce with meat (variable weight in glass jars; all product sold from June 2018 through September 11, 2018) because the product was have been manufactured under conditions that may have compromised its safety.

Europe

Food Safety Recall (Germany): JUMA GmbH recalls Ostermeier Turkey onion Mettwurst (Lot #8.335136.12; Best before 18.09.2018) due to Salmonella contamination.

Food Safety Recall (Germany): Panificio Italiano Veritas GmbH recalls REWE Beste Wahl Tomaten Oliven Brötchen (400g; Best before 30.10.2018) due to foreign matter (small pieces of glass) contamination.

Food Safety Recall (Ireland): Glanbia recalls All Avonmore Fresh Soups (Best before dates 05/10/18 and 08/10/18) due to possible foreign matter (small pieces of plastic) contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Italy): Rosselline dell’Avicola Peligna recalls Raw Shell Eggs, Cat. A (Best before 28/9/18 to 5/10/18) due to Salmonella contamination.

Food Safety Recall (Luxembourg): Delhaize recalls Duyvis brand Salted Peanuts (200g; Lot #0001005431 & 0000998957; Best before 13/07+20/07/2019) due to elevated aflatoxin levels.

Food Safety Recall (Netherlands): Zuivelhoeve recalls BOER’N YOGHURT® Appel Kaneel / Apple Cinnamon (800g; Best before 27-9-2018) due to foreign matter (soft pieces of white rubber) contamination.

Food Safety Recall (Sweden): Bergendahl Food recalls various packaged nut products due to elevated aflatoxin levels. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (UK): Dearne Valley Foods recalls McWurst Scotch Eggs (2 eggs / pack chilled; Use by 13 September 2018 to 25 September 2018) and McWurst Mini Savoury Eggs (12 eggs / pack chilled; Use by 13 September 2018 to 24 September 2018) due to potential Listeria monocytogenes contamination.

Asia, Africa and the Pacific Islands

Food Safety Recall (Hong Kong): Muji (Hong Kong) Company Limited recalls Muji brand Mini Dorayaki – Red Bean Jam Pancake (135g; Best before September 12 to December 5, 2018; Product of Japan) due to possible mold contamination.

Food Safety Recall (Singapore): MUJI (Singapore) recalls Muji brand Mini Dorayaki – Red Bean Jam Pancake (135g; Best before September 12 to December 5, 2018; Product of Japan) due to possible mold contamination.

Australia and New Zealand

Allergy Alert (Australia): Rhuby Delights recalls all Rhuby Creations Products and all Rhuby Delights Products due to an undeclared dairy ingredient. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (New Zealand): Raptor Rubs NZ Ltd recalls certain Raptor Rubs brand seasonings due to undeclared gluten, dairy, egg, tree nut, and soy. Please refer to the recall notice for a complete list of affected products.