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Ensure Harvest Nutritional and Beverage Products - recalled due to microbial contamination

1 year ago source www.fda.gov

Recall notice

United States

Lyons Magnus LLC (“Lyons Magnus” or the “Company”) is expanding its July 28, 2022, voluntary recall of Ensure Harvest nutritional and beverage products to include additional code dates. This recall is being conducted due to the potential for microbial contamination, including from the organisms Cronobacter sakazakii and Clostridium botulinum. Some products were distributed nationally, while some products were limited in scope. Products included in the recall were distributed starting in April 2021.

Consumers also are advised not to consume any products that are beyond their Best By Date. The products are packed in various formats under many different brand names, which are listed below. To identify the Lot Code and Best By Date refer to the top of the carton for individual cartons or the side of the case for multi-carton cases.

- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 330224X00. Best By Date: 01/10/2022
- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 340234X00. Best By Date: 01/11/2022
- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 340244X00. Best By Date: 01/11/2022
- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 340254X00. Best By Date: 01/11/2022
- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 390104X00. Best By Date: 01/04/2023
- Ensure Harvest Ensure Harvest 1.2 Cal For Tube Feeding 24ct/8 fl oz cartons. UPC Carton: 70074679655. UPC Case (If Sold in Cases): 70074679648. Lot Code: 390114X00. Best By Date: 01/04/2023

Although Clostridium botulinum has not been found in products, consumers are warned not to consume any of the recalled products even if they do not look or smell spoiled. The list of recalled products does not include products intended for infants (i.e., under the age of one). While infection related to Cronobacter sakazakii is rare, the common symptoms of illness could include fever, vomiting and urinary tract infection. However, vulnerable and immunocompromised populations may be more susceptible to infection.  

Clostridium botulinum may cause a severe form of food poisoning. It can begin from six hours to two weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness. Botulism poisoning can cause respiratory paralysis, resulting in death, unless assistance with breathing (mechanical ventilation) is provided. Root cause analysis indicates that the products did not meet commercial sterility specifications.

In case you experienced Cronobacter or Clostridium symptoms, report it now. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Lyons Magnus LLC
Product recalled: Nutritional and beverage products
Reason of the recall: Due to the potential for microbial contamination, including Cronobacter sakazakii and Clostridium botulinum
FDA Recall date: August 10, 2022

Source: www.fda.gov

#us #botulism #actii

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