Recalls You Should Be Aware Of—Week of August 19, 2018

We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week:

Torrent Pharmaceuticals Limited Recalls All Lots of Valsartan Products Due to Contamination

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which 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 as per International Agency for Research on Cancer (IARC) classification.

Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

For a list of products implicated in the recall, check out the official statement.

Lipari Foods Recalls Premo Brand Sandwiches Potentially Contaminated with Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of 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.

The products were produced on August 8, 2018 and distributed to food service and retail stores throughout Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

For more information on this recall, read the news release.

Radagast Pet Food Expands Recall of Products Linked to Listeria Monocytogenes

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

Listeria monocytogenes is pathogenic to humans. Healthy people exposed to Listeria monocytogenes should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea, abdominal cramping, and fever. This pathogen can cause serious and potentially fatal infections in animals consuming the pet food and in humans that handle the pet food and touch surfaces exposed to the product. There is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

The company has identified a source of potential contamination in its facility. The company has taken proactive measures to eradicate the source and it is confident that its corrective actions have eliminated the source of potential contamination related to this recall. This expanded recall will capture any additional lots that may have been affected.

To read more about this recall, consult the company announcement.

King Bio Recalls Kids and Infants Products Potentially Contaminated with Microbial Contamination

King Bio is voluntarily recalling the below products to the consumer level.

A small percentage of our products produced between 08/01/2017 and 04/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below.

Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness to date.

For a complete list of products affected by this recall, check out the news release.

BioMerieux Recalls VITEK 2 Gram Positive Antimicrobial Susceptibility Testing Cards due to Incorrect Results for Some MRSA Strains

BioMerieux is recalling the VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST for Oxacillin because of false negative or false susceptible, respectively, results for some strains of MRSA. The firm is continuing to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results. The firm is providing interim mitigations while the investigation is ongoing. This is not expected to cause a device shortage.

Gram Positive AST Cards are reagent cards used with the BioMerieux VITEK 2 and VITEK 2 Compact Systems to identify and conduct antimicrobial susceptibility testing (AST) of bacteria and yeast, which helps determine an effective antibiotic treatment for patients with a bacterial infection. The VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST for Oxacillin use the antibiotics cefoxitin and oxacillin to screen for methicillin resistant Staphylococcus aureus (MRSA), a bacterial infection that can cause problems such as skin infections, sepsis, pneumonia, or bloodstream infections.

For more information on this Class I recall, consult the official statement.

Cargill Meat Solutions Recalls Ground Beef Products Potentially Contaminated with E. Coli O157:H7

Cargill Meat Solutions, a Fort Morgan, Colo. establishment, is recalling approximately 25,288 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The problem was discovered on Aug. 22 by the establishment when they reviewed their records and determined that the product may be associated with product that was presumptive positive for E. coli O157:H7. The company then notified FSIS. There have been no confirmed reports of adverse reactions due to consumption of these products.

For more additional details related to this recall, check out the news release.