Recalls That Should Be On Your Radar—Week of December 16, 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:

Mannarich Food, Inc. Recalls Products Produced without Benefit of Import Inspection

Mannarich Food, Inc., the Importer of Record, a Toronto, Canada firm, is recalling approximately 145,245 pounds of Siluriformes products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Siluriformes products were imported to the U.S. on various dates from June 26, 2017 through November 13, 2018. The products have a shelf life of two years and all lots produced are included in the recall.

The products were imported from Malaysia, a country that is not eligible to export Siluriformes to the United States. These items were shipped to a wholesale and retail locations nationwide.

For a list of recalled products, check out the USDA’s statement.

Adam Bros. Farming Inc Recalls Products Linked to E coli Outbreak

Adam Bros. Farming, Inc. of Santa Maria, California is recalling red leaf lettuce, green leaf lettuce and cauliflower harvested on November 27 through 30, 2018 out of an abundance of caution, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).

None of the recalled product has tested positive for E. coli O157:H7. No illnesses have been reported.

As of 12/13/2018 Adam Bros. Farming, Inc. has notified its effected customers of all product that was recalled, asking that the product not be eaten, sold, or transferred. Furthermore, Adam Bros. Farming, Inc. asked that its customers notify the downline chain of custody to insure a full recall.

For a list of recalled products, check out the company’s statement.

Spokane Produce Recalls Products Due to Possible E coli Contamination

Spokane Produce Inc. of Spokane, WA initiates a voluntary recall of sandwiches containing green leaf lettuce and foodservice lettuce filets following notice of a produce industry ingredient recall by Adam Bros. Farming Inc. Sandwich products bearing the Northwest Cuisine Creations and Fresh&Local labels. These products are recalled because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7)

The affected products distributed by Spokane Produce include green leaf lettuce that was originated and recalled from Adam Bros. Farming Inc. of Santa Maria, CA. The recall was initiated after it was discovered that sediment from a reservoir near where the Adam Bros. Farm produce was grown tested positive for E.coli O157:H7. Filtered and treated water from the reservoir may have come in contact with the produce after it was harvested. None of the filtered, treated water has tested positive for E. coli, all E. coli tests returning negative.

To read more about this recall, consult the company’s statement.

Wegmans Issues Recall of Rice and Stir Fry Products Made with Cauliflower

Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).

The recall was initiated by Produce Packaging, Inc. based in Cleveland, OH, which supplies these products to Wegmans and notified Wegmans that the product may have been contaminated.

For additional information, check out the recall statement.

Apio, Inc. Recalls Salad Products Due to Potential Contamination with Listeria Monocytogenes

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart Single-Serve Salad Shake Ups (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes.

As a precautionary measure, we are recalling all products produced on the same day, same production line, as the one sample that tested positive by CFIA. At this time, we are not aware of any illnesses linked by health officials to this recall and no other products are affected by this recall.

For more information on this recall, check out the news release.

Inspired Organics Recalls Products due to Potential Contamination with Listeria Monoctyogenes

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes.

The products were distributed exclusively by Lipari Foods. LLC in Warren, Michigan to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.

This was brought to our attention after product testing initiated by Inspired Organics LLC returned positive test results for Listeria monocytogenes contamination. Inspired Organics initiated this testing out of an abundance of caution following a previous recall of a similar product which had also tested positive for contamination of Listeria monocytogenes through testing conducted by the Michigan Department of Agriculture and Rural Development (MDARD). 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.

To learn more about this product, check out the recall statement.

Medical Device Recalls:

Envoachem Pharmaceuticals Issues Recall of Dyural Convenience Kits Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Asclemed USA Inc has not received any reports of adverse events related to this recall.

The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi.

Read more about this recall by checking out the company’s statement.

Torrent Pharmaceuticals Limited Recalls Losartan Potassium Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-nitrosodiethylamine (NDEA), 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.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Learn more about this recall by checking out the recall statement.

Terrific Care, LLC Recalls CaguCheck Test Strips

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc . The products have been found to inaccurately report high INR test results.

Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

This recall is related to the recent Roche Diagnostics Recall. Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to provide INR (International Normalized Ratio) test results that correspond to the most recent INR International Standard. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected.

For additional details, check out the company statement.

FDA Warnings & Statements:

FDA Issues Warning About Increase Risk of Blood Vessel Ruptures and Tears in Some Patients Taking Fluoroquinolones

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Read the remainder of the warning on the FDA’s website.