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CORE update as of February 1, 2023

The CORE list of outbreaks and adverse events as of February 1, 2023, has shrunk to only one event.  An outbreak advisory was issued linked to Listeria monocytogenes in Enoki mushrooms to include additional products.@ https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks?utm_medium=email&utm_source=govdeliver

 

The following is a list of outbreak and adverse event investigations primarily being managed by FDA’s CORE Response Teams.

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Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to bacterial contamination

The FDA reported that Global Pharma Healthcare recalled all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination with Pseudomonas aeruginosa. The CDC alerted the FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections might be associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events, including eye infections, permanent loss of vision, and a death from a bloodstream infection. The infections, including some found in blood, urine, and lungs, were linked to EzriCare Artificial Tears. Many said they had used the product. The product was distributed Nationwide in the USA over the Internet. EzriCare, the company that markets the eye drops in the U.S., said it has stopped distributing the eye drops. It also has a notice on its website urging consumers to stop using the product. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due?utm_medium=email&utm_source=govdelivery

 

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination.

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CFIA reported that Fiber Plus Powder was recalled because it may contain Cronobacter

The CFIA reported that Ortho Molecular Products Inc (Stevens Point, WI) recalled lots of Fiber Plus from the Canadian marketplace because they may contain Cronobacter.  The recalled products include Ficus carica 228.0 milligrams, Linum usitatissimum 1.254 Grams, Plantago ovata 7.7 Grams, and Prunus domestica 228.0 milligrams. @ https://recalls-rappels.canada.ca/en/alert-recall/fiber-plus-powder-affected-lots-may-contain-presence-cronobacter-contamination?utm_source=gc-notify&utm_medium=email&utm_content=en&utm_campaign=hc-sc-rsa-22-23&

 

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Daniele International recalled Ready-to-Eat Sausage due to Listeria monocytogenes

The USDA/FSIS reported that Daniele International LLC (Mapleville, RI) recalled ~52,914 pounds of ready-to-eat (RTE) sausage products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The RTE sausage products were produced on various dates from May 23, 2022, through November 25, 2022, and shipped to retail locations nationwide on various dates from December 23, 2022, through January 17, 2023. The following products are subject to recall: 6-oz. plastic tray of FREDERIK’S by Meijer SPANISH STYLE charcuterie sampler tray; 6-oz. plastic tray of “Boar’s Head CHARCUTUERIE TRIO”; 7-oz. plastic tray of “COLAMECO’S PRIMO NATURALE GENOA UNCURED SALAMI”; 7-oz. plastic tray of “COLAMECO’S PRIMO NATURALE BLACK PEPPER UNCURED SALAMI”; 1-lb. plastic tray of “DEL DUCA SOPRESSATA, COPPA & GENOA SALAMI”; 1-lb. plastic tray of “DEL DUCA CALABRESE, PROSCIUTTO & COPPA”; 1-lb. plastic tray of “DEL DUCA GENOA SALAMI, UNCURED PEPPERONI & HARD SALAMI”; and 12-oz. plastic tray of “Gourmet Selection SOPRESSATA, CAPOCOLLO, HARD SALAME.”FSIS discovered the problem during routine inspection where Listeria monocytogenes was found on surfaces where the product came into contact. There have been no confirmed reports of adverse reactions due to the consumption of these products.  @ https://www.fsis.usda.gov/recalls-alerts/daniele-international-llc-recalls-ready-eat-sausage-products-due-possible-listeria