Category Archives: Food and Drug Administration

Blendtech Issues Allergy Alert on Undeclared Milk Allergen in Uncle Buck’s Fish Batter Mix – Original

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ucm482079BlendTech Inc of Wichita, KS, is voluntarily recalling one lot of Uncle Buck’s Fish Batter Mix – Original due to the presence of an undeclared milk ingredient. 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 recalled Batter Mix was distributed in Bass Pro Shops stores nationwide and through mail order.

The affected product is packaged in a 22 ounce, yellow plastic bottle with black cap, UPC 9222972528, and marked with lot #09241505 on the bottom of the bottle.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after BlendTech discovered product containing milk was distributed in packaging that did not reveal the presence of milk.

Consumers who have purchased the affected product are urged to discard it. Consumers who would like replacement or have questions may contact the company at 1-844-265-7354 or at 1-316-941-9660, Monday – Friday 8:00AM to 4:30PM CST.

SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo

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Dallas, TX, SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it.

Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or info@smartlipo365.com on Monday through Friday from 10 A.M. to 5 P.M. (Central time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

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The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

These actions are part of the FDA’s commitment to patient safety and ongoing efforts to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories. The FDA has been working with federal partners, manufacturers and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Within seven business days after receiving the FDA’s recall order, Custom Ultrasonics must provide a written recall proposal to the FDA.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”

AERs are Class II medical devices that require 510(k) clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses. AERs are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism.
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SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard

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640-472515Campbell Soup Company (NYSE:CPB) is voluntarily recalling 14.2 ounce cans of SpaghettiOs Original due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.

The affected 14.2 ounce SpaghettiOs Original product has a date of February 22, 2017 which is stamped on the base of the can, and a UPC code of 51000 22432 printed under the bar code.

The issue was identified after the company received consumer complaints.

This recall affects 355,000 cans and is limited to the United States.

This product should not be eaten. People who have bought the affected product should return it to the store where it was purchased for an exchange or full refund. For more information call 1-866-535-3774 between 9 a.m. to 7 p.m. EST, Monday to Friday or visit Facebook/SpaghettiOs. Campbell Soup Company apologizes for the inconvenience.

David Trail Mix Sweet & Salty Voluntarily Recalled Due To Undeclared Dairy Allergen

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daves-1DAVID® Trail Mix Sweet & Salty flavor is being voluntarily recalled by ConAgra Foods of Omaha, Nebraska, due to the presence of an ingredient in the trail mix that contains milk protein, which is not declared on the packaging.

The finished product is made for ConAgra Foods by a third party supplier who is conducting a separate recall for similar, impacted products.

This food is a concern for people who are allergic to milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume the product. ConAgra Foods was made aware of this issue through a consumer contact. ConAgra Foods is aware of one consumer allergic reaction associated with consumption of this product.

ConAgra Foods is advising consumers who have purchased this item to discard it or return it to the store where originally purchased.

This recall includes the following DAVID Trail Mix Sweet & Salty products sold as part of multi variety packages that also contain DAVID Trail Mix Classic. DAVID Trail Mix Classic is not impacted by this recall.

The DAVID Trail Mix Sweet & Salty UPC is: 26200 23885, 5oz. bags/149g.

The product was shipped to retail food stores and distributors in the U.S. and Mexico. ConAgra Foods is working with retail customers and distributors to ensure the packages are removed from store shelves.

This recall is limited to DAVID Trail Mix Sweet & Salty flavor only and does not impact other flavors of DAVID Trail Mix or any DAVID Seeds products.

Consumers with questions should call our Consumer Affairs hotline at: (800) 881-3989, open 24 hours a day/7 days a week.

One lot of “Good ‘N’ Fun – Beefhide Chicken Sticks” recalled due to possible salmonella contamination

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GoodnFun-1Deerfield, FLORIDA — Salix Animal Health, LLC today announced it has initiated a voluntary recall of one lot of “Good ‘n’ Fun – Beefhide Chicken Sticks” because it may have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products.

Healthy people infected with Salmonella should monitor themselves for some, or all, of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled “Good ‘n’ Fun – Beefhide Chicken Sticks” was distributed nationwide by Salix Animal Health to Dollar General and Dollar Tree retail stores.

The recalled product is packaged in a 2.8 ounce bag stamped on the back side with lot # AO15010 and with an expiration date of 03/2018. The UPC code is 0 91093 82247 1.

No pet or consumer illnesses from this product have been reported to date. However, because of our commitment to safety and quality, Salix Animal Health is conducting a voluntary recall of this product.

The potential for contamination was noted after routine testing by the Georgia Department of Agriculture revealed the presence of Salmonella in one 2.8 ounce package of “Good ‘n’ Fun – Beefhide Chicken Sticks” labeled with the recalled code.

No other product is affected at this time. Customers should look at the lot code and expiration date on the product package to determine if it is subject to the voluntary recall. Customers who have purchased the product subject to this recall are urged to dispose of the product or return it for full refund.

We take our responsibility to pets and their owners seriously and as a result we are investigating the cause of this problem so that we can prevent it from occurring in the future. Salix Animal Health, is also working with retailers to ensure that the affected product is no longer sold and removed from inventory.

If you have these products, please contact Salix Animal Health’s consumer affairs team at 1-800-338-4896, Monday through Friday between the hours of 8:30 AM – 5:00 PM Eastern Standard Time for a refund. Customers with questions may call the consumer affairs team at the number listed above.

OC RAW DOG Voluntarily Recalls Limited Number of Raw Frozen Dog Food Due to Potential Salmonella Health Risk

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Santa Margarita, CALIFORNIA — OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 640 lbs. of Chicken, Fish & Produce Raw Frozen Canine Formulation. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella. No illnesses have been reported and no other OC Raw Dog manufactured products are affected.

Individuals handling raw pet food can become infected with salmonella, especially if they have not thoroughly washed their hands after having contact with the product or to surfaces exposed to the product. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments including arterial infections, endocarditis, arthritis, muscle pain, eye irritation and urinary tract symptoms. If a consumer exhibits these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may have decreased appetite, fever and abdominal pain. If left untreated, pets may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

This voluntary recall is limited to Chicken, Fish & Produce Raw Frozen Canine Formulations that were packaged into 6.5 lb. Doggie Dozen Patties, 4 lb. Doggie Sliders, and 3 lb. Meaty Rox with the lot number 1819, and use by date of 05/05/16. These codes can be checked on the bottom left corner of the back of the package. Distribution is limited to customers in Colorado, Vermont, and Pennsylvania and sold to consumers through independent pet specialty retailers.

The potential for contamination was noted after routine testing by the Colorado Department of Food and Agriculture of a sample that they collected at retailer revealed the presence of Salmonella in a 3 lb. bag of “Chicken, Fish & Produce Raw Frozen Canine Formulations” Meaty Rox. Another sample from the same lot was previously tested by the California Department of Agriculture and it had a negative Salmonella result.

If you are in possession of this recalled product please submit a picture of the package with the lot number to Olivia@ocrawdog.com for verification. Either dispose of the product immediately or return the product to the retailer where you purchased it for a replacement product.

Consumers with questions may contact the company at 1-844-215-DOGS (3647) Monday thru Friday 9am – 4pm PST. If you get our automated answering system please leave a message and we will call you right back.

At OC RAW DOG, we are passionate about our products and the safety of canine and human customers is our top priority. We apologize for any inconvenience this recall may have caused.
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Cook Medical Issues Global Recall Of Beacon Tip Angiographic Catheter Products

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On July 2, 2015, Cook Medical initiated a lot-specific voluntary recall of 2,239 lots of Beacon Tip Angiographic Catheters. Globally, 95,167 devices are subject to this recall. The products include specific versions and lot numbers of the Torcon NB® Advantage Beacon® Tip Catheters (Catalog Prefix HNBR5.0), Royal Flush® Plus Beacon® Tip High-Flow Catheters (Catalog Prefix HNR4.0), and Slip-Cath® Beacon® Tip Catheters (Catalog Prefix SCBR5.0).

The Beacon Tip Angiographic Catheters have been found to exhibit tip splitting or separation, which has resulted in adverse events. Cook has received 26 complaints of catheter-tip splitting and/or separation. There have been 14 Medical Device Reports to date in which a tip split or separation occurred.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Beacon Tip Angiographic Catheters in this recall were distributed between June 2013 and June 2015. Product can be identified by the part number and lot number provided on the outer package product label. The lot numbers for products that are subject to this recall can be found on the following pages.

Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

The full list of recalled products can be found at the FDA web site.

Kent Nutrition Group, Inc. Initiates Recall of Poultry Feed

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IOWA — Kent Nutrition Group, Inc. is recalling one lot of its Blue Seal Home Fresh Starter Amp Medicated Poultry Feed. The recall is being implemented due to the discovery of excess salt in the feed concerning lot number 1015072.

Salt (sodium chloride) is an essential nutrient for all animals. However, excess salt intake can be dangerous especially if access to clean water is limited. Salt toxicity in birds results in thirst, trouble breathing, fluid discharge from the beak, wet droppings, weakness or paralysis of the legs, and even death. Customers should contact their veterinarian if their birds experienced adverse health effects while consuming the affected product.

The poultry feed being recalled was manufactured in Columbus, Nebraska. Beginning March 18 through March 25 the product was distributed to six dealerships in Nebraska. Product is sold in 50lb bags. At this time, 64- 50lb bags of Blue Seal Home Fresh Starter Amp Medicated Poultry Feed Lot 1015072 remains unaccounted for. The lot number of the product is located on the tape of the sewed-end of the bag.

The recall is the result of routine sampling by Kent Nutrition Group which indicated an excess amount of salt in the feed. Kent Nutrition Group’s products that are not from this specific lot are not affected by the recall.

TFH Publications, Inc./Nylabone Products Recalls Puppy Starter Kit

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puppy-fullTFH Publications, Inc./Nylabone Products, of Neptune, NJ is recalling one lot of its 1.69 oz. package of the Puppy Starter Kit dog chews, because they have the potential to be contaminated with Salmonella. Salmonella can affect animals ingesting the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled Puppy Starter Kit consists of one lot of dog chews that were distributed nationwide, to Canada, and through one domestic online mail order facility.

The product comes in a 1.69 oz. package marked with Lot #21935, UPC 0-18214-81291-3, located on the back of the package, and with an expiration date of 3/22/18 also stamped on the back of the package.

The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in one lot of 1.69 oz. packages of the Puppy Starter Kit.

No illnesses have been reported to date in connection with this problem.

Consumers who have purchased 1.69 oz. packages of the Puppy Starter Kit from affected Lot 21935, UPC 0-18214-81291-3, Expiration date of 3/22/18, should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-273-7527, Monday through Friday from 8:00 am – 5:00 pm Central time (after hours/weekends covered by third-party poison control center).