Recalls That Should Be On Your Radar—Week of December 9, 2018

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Food Safety Recalls:

CTI Foods LLC, Issues Recall for Pork and Poultry Sausage Products due to Potential Foreign Matter Contamination

CTI Foods LLC, an Owingsville, Ky. establishment, is recalling approximately 29,028 pounds of frozen, ready-to-eat (RTE) pork and poultry sausage links products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat sausage links items were produced and packaged on Aug. 4, 2018. The products subject to recall bear establishment number “EST. 19085” on the back of the product packaging. These items were shipped to an establishment in Tennessee where the product was further distributed to retail stores.

The problem was discovered on Dec. 10, 2018, when FSIS received notification that the establishment had received five consumer complaints of metal pieces in the RTE sausage links.

There have been no confirmed reports of adverse reactions due to consumption of these products.

To learn more about this recall, consult the USDA’s statement.

Achdut Expands Tahini Recall Due to Potential Salmonella Contamination

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.

The recalled "Tahini" was distributed internationally in retail stores and through mail orders.

The tahini products are Tahini, Whole Tahini, Organic Tahini and Seasoned Tahini. Container sizes: 15oz, 16oz, 17.6oz, 635 oz (428g, 454g, 500g, 18Kg), with lot numbers 18-097 to 18-141 or with expiration dates April 7th to May 21st 2020, while the Baron’s brand carries an expiration date of 5/5/2021. The brand names of the products are: Achdut, Baron's, S&F, Pepperwood, Soom and Achva.

To learn more about the recall expansion, check out the recall statement.

Del Monte Foods Issues Recall for Select Canned Corn Products due to Under Processing

Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed.

It is important to note that there have been no reports of illness associated with these products to date. No other production codes or products are affected by this recall.

The product was distributed to multiple distributors and retail locations in 25 states and 12 international locations.

For more information about the recalled product and a list of locations where the product was distributed, consult the company’s press release.

Inspired Organics Issues Recall for Sunflower Butter Due to Potential Contamination with Listeria Monocytogenes

Inspired Organics, LLC has issued a voluntary recall of Organic Sunflower Butter due to potential contamination of Listeria monocytogenes.

The product was distributed exclusively by Lipari Foods. LLC in Warren, Michigan to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, Tennessee, West Virginia, Wisconsin, and Ontario, Canada.

This was brought to our attention by the Michigan Department of Agriculture and Rural Development (MDARD) after product testing returned positive test results for potential for Listeria monocytogenes. We are working closely with the manufacturer, MDARD, and the Food and Drug Administration (FDA) to understand the cause of the situation and ensure that all affected product has been pulled from commerce. No illnesses have been reported to date.

Lipari Foods began shipping the product on April 17, 2018.

To read more about this recall, check out the news release.

Vermont Packinghouse, LLC Recalls Beef Products due to Contamination with Specified Risk Materials

Vermont Packinghouse, LLC, a N. Springfield, Vt. establishment, is recalling approximately 10,828 pounds of raw intact bone-in beef quarters from cattle identified as being over 30 months of age because the products may contain specified risk materials (SRM), specifically vertebral column, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The carcasses were slaughtered from Feb. 8, 2018 to June 8, 2018. The following products are subject to recall: white butcher paper wrapped packages of fresh T-bone and Porterhouse steaks from Walden Local Butcher Shop in Boston, Massachusetts.

There have been no confirmed reports of adverse reactions or injuries due to consumption of these products.

For additional details about this recall, consult the USDA’s recall announcement.

Medical Device Recalls:

GE Healthcare Recalls CareScape R860 Due to Risk of Detachment from Breathing Circuit

GE Healthcare’s CareScape R860 Inspiratory Safety Guard is a breathing accessory designed for use with the Carescape R860 Ventilator. The Carescape R860 Ventilator provides mechanical ventilation and breathing support to infants, children, and adult patients. The Carescape R860 Ventilator and the CareScape R860 Inspiratory Safety Guard are designed for use only under a healthcare professional’s order within or during transport between medical facilities.

GE Healthcare is recalling the CareScape R860 Inspiratory Safety Guard due to the risk of the device disconnecting from the patient’s breathing circuit. As the result of a manufacturing defect, the safety guard’s outlet connector may have incorrect dimensions, which could result in the device not having a secure fit with the breathing circuit. This may result in the patient not receiving breathing support.

No patient injuries have been reported, although there remains a risk of ventilation and oxygen-loss (hypoxia) should the patient’s airway become disconnected from the breathing circuit.

To read more about this medical device recall check out the FDA’s website.

Kimberly-Clark Recalls Kotex Sleek Tampons For Quality-Related Defects

Kimberly-Clark announced a voluntary product recall of its U by Kotex Sleek Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

Kimberly-Clark has received reports from consumers of the U by Kotex Sleek Tampons, Regular Absorbency, unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.

For additional information on this recall, consult the company’s announcement.

FDA Warnings & Statements:

FDA Warns Manufacturer Involved in Valsartan Recalls

The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines.

The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation.

The agency is still looking into the root cause of the impurity.

To read the warning, check out the FDA’s statement.

FDA Issues Alerts to Avoid e-Liquid Products Sold by HelloCig Electronic Technology Co.

The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil.

These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

To read the FDA’s statement, consult the drug safety statement.

FDA Announces Revisions to the VIREAD (Tenofovir Disoproxil Fumarate) Label

Revisions were made to the VIREAD (tenofovir disoproxil fumarate) label to include use in chronic hepatitis B pediatric patients ages 2 to < 12 years of age based on Week 48 safety, efficacy and pharmacokinetic data from trial GS-US-174-0144. A summary of the key changes are provided below:

• VIREAD is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
• The recommended dosage sections were revised to separate tablet dosage from the oral powder formulation dosage for ease of use by the provider, as well as to also highlight that the dose of VIREAD is the same for both HIV and HBV indications. Please refer to the label for current dosing instructions.

To read more about the label change, check out the Hepatitis Update statement.