** Abbott initiated a voluntary medical device correction in February for certain Readers in the FreeStyle Libre family of products including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.
The FreeStyle Libre family of readers use lithium-ion batteries, like the kinds used in mobile phones and many other handheld electronic devices, which have the potential for battery swelling, leakage or extreme overheating.
We have received a limited number of reports worldwide from users over several years that their Reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire. Our investigation has determined that using a charging cable or power adapter that was not included with your Reader may increase the risk of a fire hazard. The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas third-party components may allow much higher power, increasing the risk of fire if liquid or other contaminants get into the USB port.
This notice is being communicated as a voluntary medical device correction to provide information about risks associated with the lithium-ion batteries contained only in the FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers. No Readers are being physically recalled and customers can continue to use their Readers with the Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors. If you have any further questions or would like to report a device fault, please visit our Frequently Asked Questions (FAQs) or call Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time excluding major holidayswww.FreeStyleBattery.com
FSIS Issues Public Health Alert for Ready-to-Eat Meat Soup Products Due to Possible Contamination
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ready-to-eat meat soup products may have been prepared, packed, or held under insanitary conditions, which may result in the product spoiling prematurely. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.
FOR IMMEDIATE RELEASE – [NEW YORK, NY] May 01, 2023 – Del Maguey Co., New York, NY is conducting a voluntary recall of certain ceramicware cups called copitas – small artisan cups traditionally used for drinking mezcal – because they may exceed FDA guidance levels for leachable lead. Information on Lead: Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. In general, the small exposure to lead within the U.S. population does not pose a significant public health concern. However, exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age. Exposure to extremely high amounts of lead may result in overt and possibly severe symptoms for which an individual is likely to seek medical attention. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning.
**
** TruVision Health Recalls Dietary Supplement Products Because of Possible Health Risk
TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine). Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting or insomnia. These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease. Currently, hordenine is not an approved dietary ingredient in dietary supplements.
** April 26, 2023 – Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shut down all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.
Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.
The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.
Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.
Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.
For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA’s Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
April 26, 2023 – Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.
Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.
The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.
Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.
Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.
For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA’s Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Attachment I – List of Human Products (PDF – 241KB)
Attachment II – List of Veterinary Products (PDF – 202KB)
Company Contact Information
Consumers:Akorn 800-932-5676
Company Contact Information
Consumers:Akorn 800-932-5676
Kawasho Foods USA Inc. of New York, NY, is announcing an expansion of its February 26, 2023, voluntary recall of canned GEISHA Medium Shrimp 4oz. to now recall all lots of this product. Kawasho Foods is taking this step out of an abundance of caution due to a concern that there is a possibility that the product has been under processed, which could lead to the potential for spoilage organisms or pathogens.
Kawasho Foods made this decision after receiving additional information from the Food and Drug Administration. The Product was distributed to retailers nationwide (AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI) from Dec 2022 to Apr 2023.
** WASHINGTON, April 25, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ready-to-eat meat soup products may have been prepared, packed, or held under insanitary conditions, which may result in the product spoiling prematurely. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.
The following products are subject to the public health alert [view labels]:
- 48-oz. packages containing two 24-oz. cups of “Ivar’s PUGET SOUND CLAM CHOWDER WITH BACON” with Use By dates 4/26/2023, 4/27/2023, 5/3/2023, 5/4/2023, 5/5/2023, 5/11/2023, 5/23/2023, 5/30/2023, 6/2/2023, 6/6/2023, 6/7/2023, 7/5/2023, 7/20/2023, 8/1/2023, 8/10/2023, and 8/17/2023.
- 48-oz. packages containing two 24-oz. cups of “Ivar’s Loaded Baked Potato Soup” with Use By dates 5/9/2023, 5/19/2023, 6/16/2023, and 7/18/2023.
- 48-oz. packages containing two 24-oz. cups of “Ivar’s Rustic Zuppa Toscana Italian Sausage and Vegetable Soup” with Use By dates 4/30/2023, 5/2/2023, 5/14/2023, 5/15/2023, 5/21/2023, 5/22/2023, and 5/30/2023.
- 20-oz. cup of “Ivar’s PUGET SOUND Clam Chowder WITH BACON” with Use By dates 4/26/2023, 5/5/2023, 6/6/2023, 7/20/2023, and 8/10/2023.
- 20-oz. cup of “PIKE PLACE FISH MARKET WORLD FAMOUS CLAM CHOWDER WITH BACON” with Use By dates 5/4/2023, 7/5/2023, and 8/1/2023.
The products bear establishment number “EST. 20173” inside the USDA mark of inspection. These items were shipped to retail locations nationwide and exported to Mexico.
The problem was discovered when the establishment notified FSIS that they had received multiple consumer complaints regarding bloated soup packages. Upon further review, the establishment found that some product spoiled prematurely. The establishment’s lab testing of the prematurely spoiled products found high levels of spoilage bacteria in the products.
There have been no confirmed reports of illness due to consumption of these products. Anyone concerned about an illness should contact a health care provider.
Consumption of food contaminated with spoilage organisms can cause illness in immunocompromised individuals.
FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
Media with questions regarding the public health alert can contact Bob Donegan, President, Ivar’s Soup Company, at bobd@keepclam.com. Consumers with questions regarding the public health alert can contact Robert Green, Director of Technical Services, Ivar’s Soup Company, at robertg@keepclam.com.
** Kawasho Foods USA Inc. of New York, NY, is announcing an expansion of its February 26, 2023, voluntary recall of canned GEISHA Medium Shrimp 4oz. to now recall all lots of this product. Kawasho Foods is taking this step out of an abundance of caution due to a concern that there is a possibility that the product has been under processed, which could lead to the potential for spoilage organisms or pathogens.
Kawasho Foods made this decision after receiving additional information from the Food and Drug Administration.
The Product was distributed to retailers nationwide (AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI) from Dec 2022 to Apr 2023.
The GEISHA Medium Shrimp is packaged in a 4oz. metal can, with UPC 071140003909 (Listed on the back of the label).
This event only affects this specific product.
Consumers should not use this product, even if it does not look or smell spoiled. No illnesses or other adverse consequences have been reported to date in connection with this product.
Consumers who have purchased this product are urged to return to place of purchase for a full refund. If you have any question regarding this recall, please contact us at Toll Free (224)278-9935 (Monday to Friday, 9:00 a.m. to 5 p.m. EST) or via email at info@geishabrand.com.
**
** GRAND RAPIDS, Mich., April 7, 2023 — Meijer, in conjunction with its supplier, Revolution Farms, is announcing a voluntary recall of select Fresh From Meijer premade salads because they have the potential to be contaminated with 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 recall is part of a broader Revolution Farms lettuce recall and includes premade salads carried at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin. Meijer is not aware of any illnesses from Meijer brand salad products included in this recall.
The recalled premade salads have a Fresh From Meijer sticker on a clear plastic container. The following products are part of the recall:
| UPC | Recalled Product Name | Sell By Date(s) |
|---|---|---|
| 7-08820-30432-1 | Fresh From Meijer Cranberry Spinach Shareable Salad (12 oz.) | All |
| 7-13733-07493-3 | Fresh From Meijer Salad Bowl Spinach Dijon Salad (6.15 oz.) | All |
| 7-13733-24610-1 | Fresh From Meijer Tomato Caprese Salad (6 oz.) | All |
| 7-13733-24611-8 | Fresh From Meijer Avocado Chicken Bacon Ranch Salad (8 oz.) | All |
| 7-13733-24613-2 | Fresh From Meijer Mediterranean Salad (6.5 oz.) | All |
| 7-13733-29537-6 | Fresh From Meijer Shareable Garden Salad (11.5 oz.) | All |
| 7-19283-67929-1 | Fresh From Meijer Michigan Harvest Salad (6.7 oz.) | All |
| 7-19283-67930-7 | Fresh From Meijer Chicken BLT Salad (8.2 oz.) | All |
| 7-19283-67932-1 | Fresh From Meijer Cobb Salad (8.8 oz.) | All |
| 7-19283-67933-8 | Fresh From Meijer Chicken Caesar Shareable Salad (10 oz.) | All |
| 7-60236-11745-2 | Fresh From Meijer Chicken Caesar Salad (6.4 oz.) | All |
| 7-60236-48832-3 | Fresh From Meijer Southwest Chicken Salad (8.8 oz.) | All |
Customers who have purchased any of these products should immediately throw them away. A full refund can be requested at the Customer Service desk of the nearest Meijer store. Customers with questions regarding this recall can contact Meijer at 800-543-3704 from 7:00 AM – 1:00 AM (EDT) daily. Customers with questions or concerns about their health are encouraged to contact their primary care provider.
Fresh Express Incorporated is voluntarily recalling a limited quantity of three varieties of already-expired branded and private label salad kit products produced at the company’s Morrow, Georgia facility out of an abundance of caution due to a possible health risk from Listeria monocytogenes. The recalled products are no longer available for sale and no illnesses have been reported to date.Listeria monocytogenes 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. Consumers with these symptoms should consult their health care provider.
** WARREN, Mich. – Lipari Foods has issued a voluntary recall of a specific lot of Lipari Branded Ground Cumin Tubs manufactured by International Food due to potential presence of Salmonella contamination. Salmonella is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The products were distributed to retail stores throughout Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin.
Products were distributed as generic product with “Distributed by Lipari Foods” listed on the label.
The affected products can be identified by:
| Brand | Product | Size | Lot Code | Best By Date | UPC |
|---|---|---|---|---|---|
| LIPARI | GROUND CUMIN | 6 OZ. TUB | 220914601 | 09/2024 | 094776212620 |
There are no reported illnesses in connection with this product to date.
This was brought to our attention by The United States Food and Drug Administration (FDA) and The Michigan Department of Agriculture and Rural Development (MDARD), after they were alerted that a sample of the Ground Cumin collected by the Florida Department of Agriculture and Consumer Services tested positive for Salmonella. The Lipari Branded Ground Cumin Tubs manufactured by International Food are being recalled as they are potentially adulterate with Salmonella. We are working closely with the FDA to ensure that all affected product has been pulled from commerce.
Consumers who have purchased this recalled product should not consume it. They should return it to the point of purchase. Consumers with questions should call Customer Service at 800-729-3354, 8:15 am – 4:30 pm, EST, Monday through Friday.
** Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks by O&M Halyard.
The FDA is aware of laboratory test results that show certain models of O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer. The FDA is continuing its evaluation.
This safety communication provides:
- A list of surgical N95 respirators to stop using.
- A list of surgical masks (including procedure masks) and pediatric face masks to not use when fluid barrier protection against splashes, sprays, or splatter is needed
- Recommendations for consumers, health care providers, and facilities.
- The FDA’s actions to address the issue.
- Instructions for reporting problems to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
** GRAND RAPIDS, Mich., April 7, 2023 — Meijer, in conjunction with its supplier, Revolution Farms, is announcing a voluntary recall of select Fresh From Meijer premade salads because they have the potential to be contaminated with 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 recall is part of a broader Revolution Farms lettuce recall and includes premade salads carried at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin. Meijer is not aware of any illnesses from Meijer brand salad products included in this recall.
The recalled premade salads have a Fresh From Meijer sticker on a clear plastic container. The following products are part of the recall:
| UPC | Recalled Product Name | Sell By Date(s) |
|---|---|---|
| 7-08820-30432-1 | Fresh From Meijer Cranberry Spinach Shareable Salad (12 oz.) | All |
| 7-13733-07493-3 | Fresh From Meijer Salad Bowl Spinach Dijon Salad (6.15 oz.) | All |
| 7-13733-24610-1 | Fresh From Meijer Tomato Caprese Salad (6 oz.) | All |
| 7-13733-24611-8 | Fresh From Meijer Avocado Chicken Bacon Ranch Salad (8 oz.) | All |
| 7-13733-24613-2 | Fresh From Meijer Mediterranean Salad (6.5 oz.) | All |
| 7-13733-29537-6 | Fresh From Meijer Shareable Garden Salad (11.5 oz.) | All |
| 7-19283-67929-1 | Fresh From Meijer Michigan Harvest Salad (6.7 oz.) | All |
| 7-19283-67930-7 | Fresh From Meijer Chicken BLT Salad (8.2 oz.) | All |
| 7-19283-67932-1 | Fresh From Meijer Cobb Salad (8.8 oz.) | All |
| 7-19283-67933-8 | Fresh From Meijer Chicken Caesar Shareable Salad (10 oz.) | All |
| 7-60236-11745-2 | Fresh From Meijer Chicken Caesar Salad (6.4 oz.) | All |
| 7-60236-48832-3 | Fresh From Meijer Southwest Chicken Salad (8.8 oz.) | All |
Customers who have purchased any of these products should immediately throw them away. A full refund can be requested at the Customer Service desk of the nearest Meijer store. Customers with questions regarding this recall can contact Meijer at 800-543-3704 from 7:00 AM – 1:00 AM (EDT) daily. Customers with questions or concerns about their health are encouraged to contact their primary care provider.
** The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. This includes stating for all opioid pain that the risk of overdose increases as the dose increases.
- The updates to IR opioids state these products should not be used for an extended period unless the pain remains severe enough to require them and alternative treatments continue to be inadequate, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine. This may include pain occurring with a number of surgical conditions or musculoskeletal injuries.
- The FDA is also updating the approved use for ER/LA opioid pain medicines to recommend they be reserved for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- The FDA is also adding a new warning about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the Boxed Warning, FDA’s most prominent warning, for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes are also being required to several sections of the prescribing information, including to the Indications and Usage, Dosage and Administration, and Warnings and Precautions sections. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.
BACKGROUND: Opioid pain medicines are a class of powerful pain medicines prescribed to treat pain that does not respond well to other treatments or non-opioid pain medicines. They activate an area of nerve cells in the brain and body that block pain signals. These medicines have benefits when used appropriately, but they also have serious risks, including misuse and abuse, addiction, overdose, and death. Examples of common opioid pain medicines include codeine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, fentanyl, buprenorphine, and tramadol.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
**
** 001-2023, Daniele International LLC Recalls Ready-to-Eat Sausage Products Due to Possible Listeria Contamination (Jan 29, 2023)
004-2023, Delight Foods USA LLC Recalls Ineligible Frozen Siluriformes Products Imported from India (Feb 3, 2023)
** January of 2023, Conagra Brands, Inc., a Fort Madison, Iowa establishment, is recalling approximately 2,581,816 pounds of canned meat and poultry products due to a packaging defect that may cause the products to become contaminated without showing any outward signs of contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The meat and poultry products were produced between December 12, 2022, and January 13, 2023. The following products are subject to recall: [view spreadsheet] [view labels].
The products subject to recall bear establishment number “P4247” on the product cans. These items were shipped to retail locations nationwide.
The problem was discovered when the establishment notified FSIS after observing spoiled and/or leaking cans from multiple production dates at the establishment’s warehouse.
Subsequent investigation by the establishment determined that the cans subject to recall may have been damaged in a manner that is not readily apparent to consumers, which may allow foodborne pathogens to enter the cans.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
FSIS is concerned that some product may be on retail shelves or in consumers’ pantries. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Members of the media with questions about the recall can contact Dan Hare, Senior Director of Communications, ConAgra Brands, at 312-549-5355 or daniel.hare@conagra.com. Consumers with questions about the recall can call 800-289-6014, Monday-Friday 9 a.m. to 5 p.m. CST or email consumer.care@conagra.com.
Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.
** Revolution Farms of Caledonia, Michigan is voluntarily recalling the listed products packed between 3/3/23 and 3/11/23, because they have the potential to be contaminated with Listeria monocytogenes, 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.
No illnesses have been reported to date. If you think you may have become ill from something you ate, seek immediate medical attention. The recall was initiated when the Michigan Department of Agriculture and Rural Development (MDARD) received a positive result for Listeria monocytogenes in a random sample test of a single package of Revolution Farms Green Sweet Crisp – 5oz Retail with Best By date of April 2, 2023.
The recalled products were sold to the following retailers and food service distributors in the states of MI, OH, IN, IL, KY, and WI: SpartanNash stores, Meijer stores, Bridge St. Market, Kingma’s Market, Fresh Thyme Market Grand Rapids, Fresh Thyme Market Kalamazoo, Horrocks Market Grand Rapids, Doorganics, Cherry Capital Foods, Gordon Food Service, Van Eerden Foodservice, Vine Line Produce, Luna restaurant, Russ’ Commissary, and Pearson Foods Corporation.
All recalled products were distributed under the Revolution Farms brand name. Only the products and product codes listed in the table are included in the recall. The full list of recalled products is below:
| Product | Packaging | Product Code | UPC Code |
|---|---|---|---|
| Great Lakes Gourmet 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008028 |
| Green Sweet Crisp 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008141 |
| Michigan Spring Mix 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008004 |
| Robust Romaine 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008035 |
| Romaine Lettuce Boats 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008196 |
| Sweet Crisp Deli Leaf 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008189 |
| Whole Leaf Romaine 5oz Retail | Plastic tray, lidding film | Best By 3/28/23 – 4/5/23 | 856791008202 |
| Sesame Ginger Crunch 6 oz Salad Kit | Plastic tray, label | Sell By 3/23/23 | 856791008233 |
| Traverse City Cherry 6 oz Salad Kit | Plastic tray, label | Sell By 3/23/23 | 856791008226 |
| Zesty Southwest 6 oz Salad Kit | Plastic tray, label | Sell By 3/23/23 | 856791008240 |
| Farmer’s Mix 3lb Bulk | Clear poly bag | Packaged On 3/3/23 – 3/11/23 | 856791008134 |
| Great Lakes Gourmet 3lb Bulk | Clear poly bag | Packaged On 3/3/23 – 3/11/23 | 856791008066 |
| Green Sweet Crisp 3lb Bulk | Clear poly bag | Packaged On 3/3/23 – 3/11/23 | 856791008172 |
| Michigan Spring Mix 3lb Bulk | Clear poly bag | Packaged On 3/3/23 – 3/11/23 | 856791008042 |
| Robust Romaine 3lb Bulk | Clear poly bag | Packaged On 3/3/23 – 3/11/23 | 856791008127 |
5oz Retail packages are clear, plastic trays sealed with printed lidding film and have a Best By date stamped on the bottom of the tub. 6oz Salad Kits are clear plastic tubs with a wrap label and have a Sell By date stamped on the side of the container. 3lb Bulk packages are clear, plastic bags packed 1 bag to a case with a Packaged On date stamped on the case label. Pictures to assist customers in identifying the recalled products are found at the end of this announcement.
Revolution Farms is cooperating with the Michigan Department of Agriculture and Rural Development on this ongoing investigation.
Affected retailers have been instructed to remove all recalled products from store shelves. Consumers who have purchased the recalled products should discard them or return them to their place of purchase for a full refund. Consumers with questions are encouraged to call Trent Hartwig, President Monday to Friday from 9AM to 5PM at (616) 893-1748 or email info@revolutionfarms.com with the subject line: Recall.
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