FDA/USDA ~ November ~updates for October ~ Alerts &Safety ~ 2020


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Tarantino Wholesale Foods Distributor, a San Diego, Calif., establishment, is recalling approximately 1,115 pounds of ready-to-eat chicken breast products due to undercooking, resulting in the potential survival of bacterial pathogens in the products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat grilled chicken breast items were produced on October 23, 2020. The following products are subject to recall: [View Label]

  • 10-lb. cases of “MARY’S FULLY COOKED CHICKEN BREAST” with lot code 20297 and use by date 10/23/21.

The cases containing the products subject to recall bear establishment number “P-8119” inside the USDA mark of inspection. These items were shipped to institution locations in California and were sold directly to retail consumers.            

The problem was discovered when the firm received a customer complaint that the ready-to-eat chicken product appeared to be undercooked.

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.  

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 list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.        

Consumers with questions regarding the recall can contact Marcos Tarantino, Quality Assurance Supervisor, at marcos.tarantino@tarantinosausage.com. Media with questions regarding the recall can contact Pete Tarantino, CEO, at (619) 232-7585.

** Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora.

These were packed under branded and private label fresh cut organic certified basil clamshells at its Jefferson, GA facility and Harrisonburg, VA facility with the following lot codes, all with the country of origin of Colombia. Recalled products were distributed to select retail stores between 10/20/2020 and 10/30/2020 in various states including Georgia, Tennessee, Florida, Virginia, Pennsylvania, Maryland, Connecticut, Delaware, New Jersey, New York, and Washington DC.

Affected lot codes:

LOT Number:Brand:Size:UPC:
PV14334C296The Fresh Market0.5oz7-37094-23027-2
PV64308E304Good & Gather0.5oz0-85239-12215-0
PV64308C296Naturally Better0.5oz6-07880-20230-4
PV64308A300Naturally Better0.5oz6-07880-20230-4
PV64308D300Naturally Better0.5oz6-07880-20230-4
PV14334E297Nature’s Promise4.0oz6-88267-16220-6
PV14334E297Nature’s Promise2.5 oz6-88267-54893-2
PV14334E297Nature’s Promise0.5oz6-88267-19910-3
PV14334B296Nature’s Promise0.5oz6-88267-19910-3
PV14334C297O Organics0.66oz0-79893-98072-0
PV 14334E297O Organics4.0oz0-79893-98081-2
PV64308B294Simple Truth3.0oz0-11110-00876-3
PV64308D297Simple Truth3.0oz0-11110-00876-3
PV64308E295That’s Tasty3.0oz7-68573-53001-9
PV64308E296That’s Tasty2.0oz7-68573-51510-8
PV64308A298That’s Tasty3.0oz7-68573-53001-9
PV14334C296Wild Harvest0.25oz7-11535-50450-4
PV14334C296Wild Harvest4.0oz7-11535-50323-1
PV14334C296Wild Harvest2.0oz7-11535-50762-8

The Shenandoah Growers recall includes only those clamshells of certified organic basil clearly marked with the affected lot codes listed above. The lot code can be found printed on each clamshell.

This precautionary recall notification is being issued due to an isolated instance in which a package pulled by the Florida Department of Agriculture on 11/2/2020 from a retail store in Florida indicated the potential presence of Cyclospora.

Affected Shenandoah Growers customers have been notified of the recall and instructed to immediately remove and discard recalled products from all store shelves, distribution and other inventories to ensure they are no longer available for sale or consumption.

These products were harvested and packed nearly 4 weeks ago and should no longer be in commerce.

Cyclosporiasis is an intestinal infection caused by the Cyclospora parasite. A person may become infected after ingesting contaminated food or water. Common symptoms include severe abdominal pain, diarrhea, nausea and vomiting, body aches and fatigue. The infection is treated with antibiotics and most people respond quickly to treatment.

No other Shenandoah Growers products are subject to recall, and the company has no knowledge of any illness reported or related to this product.

Consumers who may have a recalled basil product should discard it immediately and not eat it. Consumers with questions, or to obtain refunds, may contact the Shenandoah Growers Consumer Response Center at 844-896-6939 Monday through Friday, 8 am to 5 pm Eastern time.

**Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered during routine safety sampling at Hy-Vee’s Short Cuts production facility. To date, no illnesses have been reported in connection with these products.

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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

Out of an abundance of caution, Hy-Vee is recalling the following products from all of its stores:

  • Hy-Vee Short Cuts Pot Roast Mix – UPC Code 0272083305352
  • Hy-Vee Short Cuts Grill/Oven Ready Veggie Mix – UPC Code 0272104105992

All affected products have a “Best if Used By” date of Dec. 3, 2020. Photos of the affected product labels are attached. No other Hy-Vee Short Cuts products or products used in Hy-Vee stores are affected by this recall.

Customers who purchased any of these products with these dates should not consume them. Customers are being asked to discard these items or return them to their local Hy-Vee store for a full refund.

Consumers with questions may contact Hy-Vee Customer Care representatives 24 hours a day, seven days a week at (800) 772-4098.

** Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

Product Name/Product sizeNDC NumberProduct CodeBatch NumberExpiration DateFirst Ship DateLast Ship Date
Dexmedetomidine HCl in 0.9%
Sodium Chloride Injection, 200 mcg /
50 mL (4 mcg / mL), 50 mL fill in a  50 mL vial
63323-671-50671050612392503/202204/09/202004/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.freseniuskabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.External Link Disclaimer

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

** The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) chicken and pork tamale products containing Food and Drug Administration (FDA) regulated diced tomatoes in puree that have been recalled by the producer, due to concerns that the products may be contaminated with extraneous materials, specifically hard plastic. The hard plastic may pose a choking hazard or cause damage to teeth or gums. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products, which bear the USDA mark of inspection, should not be consumed.

The frozen RTE chicken and pork tamale items were produced between Oct. 22, 2020 and Nov. 9, 2020 by Tucson Tamale Wholesale Co. LLC, an establishment in Tucson, Ariz.  The following products are subject to the public health alert: [View Labels (PDF only)]

  • Cases containing eight individually packed tamales with the labels “TUCSON TAMALE GREEN CHILE CHICKEN TAMALE” or “TUCSON TAMALE Green Chile Chicken Tamales” with lot codes F20296 and F20309 and sell by dates of 10/23/22 and 11/05/22.
  • Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE CHICKEN TAMALES” with lot codes F20309 and F20296 and sell by dates of 10/23/22 and 11/05/22.
  • Cases containing 30 tamales of “TUCSON TAMALE Green Chile Pork & Cheese Tamales” with lot codes F20303 and F20307 and sell by dates of 10/30/22 and 11/03/22.
  • Cases containing eight individually packed tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALE” with lot codes F20307 and F20314 and sell by dates of 11/03/22 and 11/10/22.
  • Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303 and F20307 and sell by dates 10/30/22 and 11/03/22.
  • Packages containing two tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303, F20307 and F20302 and sell by dates of 10/29/22, 10/30/22 and 11/03/22.
  • Cases containing 30 tamales of “TUCSON TAMALE Green Chile Chicken Tamales” with lot code F20296 and sell by date of 10/23/22.

The products bear establishment number “EST. 45860” inside the USDA mark of inspection. These items were sold online and also shipped to distributors for further distribution to retail locations and restaurants nationwide.

The problem was discovered by Tucson Tamale Wholesale Co. when they identified pieces of hard plastic in the cans of diced tomatoes in puree that they received from their ingredients supplier. The ingredients supplier initiated a recall of the diced tomatoes in puree with the FDA. As more FDA information becomes available, FSIS will update this public health alert.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a health care provider.

FSIS is concerned that some product may be in consumers’ 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.

Consumers and members of the media with questions can contact Sherry Martin, CEO of Tucson Tamale Wholesale Co., at (520) 398-6282.

**  The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) chicken and pork tamale products containing Food and Drug Administration (FDA) regulated diced tomatoes in puree that have been recalled by the producer, due to concerns that the products may be contaminated with extraneous materials, specifically hard plastic. The hard plastic may pose a choking hazard or cause damage to teeth or gums. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products, which bear the USDA mark of inspection, should not be consumed.

The frozen RTE chicken and pork tamale items were produced between Oct. 22, 2020 and Nov. 9, 2020 by Tucson Tamale Wholesale Co. LLC, an establishment in Tucson, Ariz.  The following products are subject to the public health alert: [View Labels (PDF only)]

 The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) chicken and pork tamale products containing Food and Drug Administration (FDA) regulated diced tomatoes in puree that have been recalled by the producer, due to concerns that the products may be contaminated with extraneous materials, specifically hard plastic. The hard plastic may pose a choking hazard or cause damage to teeth or gums. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products, which bear the USDA mark of inspection, should not be consumed.

The frozen RTE chicken and pork tamale items were produced between Oct. 22, 2020 and Nov. 9, 2020 by Tucson Tamale Wholesale Co. LLC, an establishment in Tucson, Ariz.  The following products are subject to the public health alert: [View Labels (PDF only)]

  • Cases containing eight individually packed tamales with the labels “TUCSON TAMALE GREEN CHILE CHICKEN TAMALE” or “TUCSON TAMALE Green Chile Chicken Tamales” with lot codes F20296 and F20309 and sell by dates of 10/23/22 and 11/05/22.
  • Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE CHICKEN TAMALES” with lot codes F20309 and F20296 and sell by dates of 10/23/22 and 11/05/22.
  • Cases containing 30 tamales of “TUCSON TAMALE Green Chile Pork & Cheese Tamales” with lot codes F20303 and F20307 and sell by dates of 10/30/22 and 11/03/22.
  • Cases containing eight individually packed tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALE” with lot codes F20307 and F20314 and sell by dates of 11/03/22 and 11/10/22.
  • Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303 and F20307 and sell by dates 10/30/22 and 11/03/22.
  • Packages containing two tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303, F20307 and F20302 and sell by dates of 10/29/22, 10/30/22 and 11/03/22.
  • Cases containing 30 tamales of “TUCSON TAMALE Green Chile Chicken Tamales” with lot code F20296 and sell by date of 10/23/22.

The products bear establishment number “EST. 45860” inside the USDA mark of inspection. These items were sold online and also shipped to distributors for further distribution to retail locations and restaurants nationwide.

The problem was discovered by Tucson Tamale Wholesale Co. when they identified pieces of hard plastic in the cans of diced tomatoes in puree that they received from their ingredients supplier. The ingredients supplier initiated a recall of the diced tomatoes in puree with the FDA. As more FDA information becomes available, FSIS will update this public health alert.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a health care provider.

FSIS is concerned that some product may be in consumers’ 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.

Consumers and members of the media with questions can contact Sherry Martin, CEO of Tucson Tamale Wholesale Co., at (520) 398-6282.

The products bear establishment number “EST. 45860” inside the USDA mark of inspection. These items were sold online and also shipped to distributors for further distribution to retail locations and restaurants nationwide.

The problem was discovered by Tucson Tamale Wholesale Co. when they identified pieces of hard plastic in the cans of diced tomatoes in puree that they received from their ingredients supplier. The ingredients supplier initiated a recall of the diced tomatoes in puree with the FDA. As more FDA information becomes available, FSIS will update this public health alert.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a health care provider.

FSIS is concerned that some product may be in consumers’ 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.

Consumers and members of the media with questions can contact Sherry Martin, CEO of Tucson Tamale Wholesale Co., at (520) 398-6282.

** Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Organic Romaine Hearts (UPC 7-11535-50201-2), with Harvested-On dates of 10-23-20 and 10-26-20.  The recall is being conducted due to a possible health risk from E. coli in the two products.  Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported to date in association with the recall. 

Pathogenic E. coli can cause diarrhea, severe stomach cramps and vomiting.  Most people recover within a week, but some illnesses can last longer and can be more severe.

The Harvested-On sticker is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The Dole package contains three organic romaine hearts and the Wild Harvest product is packaged in a 12oz bag. The impacted products were distributed in AZ, HI, IA, IL, IN, KS, MD, MI, MN, MO, MS, MT, NC, ND and VA. These products were harvested and packed nearly 4 weeks ago and should no longer be in commerce.  Consumers are advised to check product they have in their homes and discard any product matching the production description, UPC codes and Harvested-On dates listed above.

This precautionary recall notification is being issued due to an isolated instance in which a package of Dole™ Organic Romaine Hearts – 3pk yielded a positive result for pathogenic non-O157 E.coli STEC in a routine sample collected at a retail store by the Michigan Department of Agriculture and Rural Development. There is no indication at this time that this positive result is related to any illnesses nor consumer complaints and it is not associated with the strains connected to the ongoing outbreaks currently under regulatory investigation. 

No other Dole products are included in the recall. This voluntary recall does not apply to any bagged or clamshell salad romaine product. Only the specific Organic Romaine Hearts listed, with the exact UPC codes and Harvested-On dates identified above, are included in the recall. Consumers who have any remaining product with these UPC codes and Harvested-On dates should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center at 1-800-356-3111, which is open 24 hours a day.

**Fusion Health and Vitality LLCis voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.

Fusion Health and Vitality LLC has not received any reports of adverse events related to this recall.  Please review the attached photos for identification.

We began shipping Core Essential Nutrients on 1/2/2020 and we began shipping Immune Boost Sublingual Vitamin D3 on 4/15/2020.

Both products are packaged with labels which prominently display the product name.  CORE essential nutrients are found in a dark colored jar, in powdered format.  This product was formulated to mix into a liquid before consumption.

The Immune Boost sublingual was packaged in a 2 ounce bottle that came with a sublingual application dropper.

Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products.

Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction.

Consumers with questions regarding this recall or how to return recalled product can contact Fusion Health and Vitality by calling 1-888-964-5327, 9am to 5pm, Monday Thru Friday, EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) chicken and pork tamale products containing Food and Drug Administration (FDA) regulated diced tomatoes in puree that have been recalled by the producer, due to concerns that the products may be contaminated with extraneous materials, specifically hard plastic. The hard plastic may pose a choking hazard or cause damage to teeth or gums. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products, which bear the USDA mark of inspection, should not be consumed.

The frozen RTE chicken and pork tamale items were produced between Oct. 22, 2020 and Nov. 9, 2020 by Tucson Tamale Wholesale Co. LLC, an establishment in Tucson, Ariz.  The following products are subject to the public health alert: [View Labels (PDF only)]Cases containing eight individually packed tamales with the labels “TUCSON TAMALE GREEN CHILE CHICKEN TAMALE” or “TUCSON TAMALE Green Chile Chicken Tamales” with lot codes F20296 and F20309 and sell by dates of 10/23/22 and 11/05/22.

Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE CHICKEN TAMALES” with lot codes F20309 and F20296 and sell by dates of 10/23/22 and 11/05/22.

Cases containing 30 tamales of “TUCSON TAMALE Green Chile Pork & Cheese Tamales” with lot codes F20303 and F20307 and sell by dates of 10/30/22 and 11/03/22.

Cases containing eight individually packed tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALE” with lot codes F20307 and F20314 and sell by dates of 11/03/22 and 11/10/22.

Cases containing six packages with two tamales each of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303 and F20307 and sell by dates 10/30/22 and 11/03/22.

Packages containing two tamales of “TUCSON TAMALE GREEN CHILE PORK & CHEESE TAMALES” with lot codes F20303, F20307 and F20302 and sell by dates of 10/29/22, 10/30/22 and 11/03/22.

Cases containing 30 tamales of “TUCSON TAMALE Green Chile Chicken Tamales” with lot code F20296 and sell by date of 10/23/22.

The products bear establishment number “EST. 45860” inside the USDA mark of inspection. These items were sold online and also shipped to distributors for further distribution to retail locations and restaurants nationwide.

The problem was discovered by Tucson Tamale Wholesale Co. when they identified pieces of hard plastic in the cans of diced tomatoes in puree that they received from their ingredients supplier. The ingredients supplier initiated a recall of the diced tomatoes in puree with the FDA. As more FDA information becomes available, FSIS will update this public health alert.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a health care provider.

FSIS is concerned that some product may be in consumers’ 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.

Consumers and members of the media with questions can contact Sherry Martin, CEO of Tucson Tamale Wholesale Co., at (520) 398-6282.

**Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.

The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free is distributed in cases each containing 50 unit dose cups. Each case contains a colored label around the lid and body of the case.

The product can be identified by as shown in the images below:

Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free was distributed to Nationwide to hospital pharmacies.

Lohxa, LLC is notifying its direct customers by Fedex overnight mail, electronic mail, phone call and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below: AFFECTED LOTS

Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free, 15 mL (NDC:70166-027-15)
LOTEXP
T09101A01/2021
T08292A02/2021
T10011A02/2021
M10193A03/2021
T10223A03/2021

*Tanimura & Antle voluntarily recalled its packaged single head romaine lettuce due to possible contamination with E. coli.

Out of an abundance of caution, Tanimura & Antle Inc. is voluntarily recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, due to possible contamination with E. Coli 0157:H7. Packages contain a single head of romaine lettuce with the UPC number 0-27918-20314-9. No other products or pack dates are being recalled. There have been no reported illnesses associated with the recalled product.

The recall is being conducted in consultation with FDA, and is based on the test result of a random sample collected and analyzed by the Michigan Department of Agriculture and Rural Development as part of their routine sampling program. A total of 3,396 cartons of potentially affected product were distributed in the United States to the following states: AK, OR, CA, TX, AR, OK, IN, NE, MO, TN, WI, NM, SC, WA, NC, OH, VA, MA, PR, and IL. The potentially affected product was shipped in cases packed in either 12, 15, 18 or 24 heads per case. Retailers and distributors can identify the potentially affected products through the Produce Traceability Initiative (PTI) sticker attached to exterior of the case. The PTI codes are 571280289SRS1 and 571280290SRS1.

E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. If consumers are experiencing any of the above symptoms, please contact your physician.

At Tanimura & Antle, food safety is a number one priority and the company prides itself on its preventative measures. It is unlikely that this product remains at retail establishments due to the shelf life of lettuce and the number of days that have passed. We are asking that if any of the packaged single head romaine described above is in the possession of consumers, retailers or distributors, the product be disposed of and not consumed.

Consumers with questions or concerns may call the Tanimura & Antle Consumer Hotline at 877-827-7388 Monday – Friday, 8:00 AM – 5:00 PM.

*GM recalls 217K vehicles to fix leak causing cars to stop moving, possibly catch fire

The recall covers certain versions of the 2018 through 2020 Chevrolet Equinox and Traverse as well as the GMC Terrain. Also included are the 2018 Chevrolet Malibu and 2018 and 2019 Chevrolet Cruze and Buick LaCrosse, as well as the 2019 through 2020 Buick Encore and Enclave, the Cadillac XT4, GMC Acadia and Chevrolet Blazer. The 2020 Cadillac XT6 also is covered.

More:GM reports quarter gain, says it can handle election results, rising COVID-19

More:GM fast-tracks electric vehicle plans, starts hiring near former Lordstown plant

GM says in government documents posted last weekend that two bolts may be missing from the stop-start mechanism, allowing the fluid to leak. The company says it has no reports of crashes, fires or injuries.

Dealers will inspect the mechanism and replace bolts if they’re missing. The recall is expected to start Dec. 14.

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.

1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified by as shown in the images below:

Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below:

AFFECTED LOTS

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% NDC # 052376-021-02 P/N 1789P 16 fl oz
Lot #Exp DateLot #Exp DateLot #Exp Date
C170FY6/30/22C191KT7/31/22C205BL7/31/22
C170FZ6/30/22C191KU7/31/22C205BM7/31/22
C170GA6/30/22C191KW7/31/22C205BN7/31/22
C170GB6/30/22C191KX7/31/22C219DS8/31/22
C170GC6/30/22C191KY7/31/22C240GM9/30/22
C177GP6/30/22C198LJ7/31/22C219DK8/31/22
C177GQ6/30/22C198LK7/31/22C219DL8/31/22
C177GR6/30/22C198LL7/31/22C219DM8/31/22
C240GP9/30/22C198LM7/31/22C219DN8/31/22
C240GQ9/30/22C205BH7/31/22C219DP8/31/22
C240GR9/30/22C205BJ7/31/22C219DQ8/31/22
C191KS7/31/22C205BK7/31/22C219DR8/31/22
Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% NDC # 052376-021-04 P/N 1788P 4.0 fl oz
Lot #Exp Date
C191KR7/31/22

Adverse reactions or quality problems experienced with the use of this product 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

Regular Mail or Fax: Download form 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

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

For more information:
Contact us:
Phone: 1-800-528-8537

*Homestead Creamery of Wirtz, VA is voluntarily recalling glass bottled products because of a suspected issue with the bottle sanitizing process. Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk associated with the issue at this time.

Affected products include:

ProductUPCBest Buy Dates
A2A2 2% half gallon875252000289Nov 8
Creamline Whole Milk half gallon875252000074Nov 4, Nov 8, Nov 9
Homogenized Whole Milk half gallon875252000173Nov 4, Nov 8, Nov 9
Homogenized Whole Milk quart875252000159Nov 5, Nov 8, Nov 9
2% Milk half gallon875252000272Nov 4, Nov 8, Nov 9
2% Milk quart875252000258Nov 4, Nov 8, Nov 9
Non-Fat Creamline Milk half gallon875252000371Nov 4, Nov 8, Nov 9
Non-Fat Creamline Milk quart875252000357Nov 8, Nov 9
Chocolate Milk half gallon875252000470Nov 4, Nov 8, Nov 9
Chocolate Milk quart875252000456Nov 4, Nov 5, Nov 9
Orange Cream Milk quart875252000623Nov 8
Cowpuccino Milk quart875252000760Nov 8
Heavy Cream quart875252000890Nov 4, Nov 8, Nov 9
Half and Half quart875252000869Nov 8, Nov 9
Buttermilk quart875252000821Nov 29
Lemonade half gallon875252002658Dec 19, Dec 20
Eggnog quart returnable bottle875252000982Nov 15
Old Fashioned Custard quart returnable bottle875252000920Nov 15
Eggnog half gallon returnable bottle875252000999Nov 15
Eggnog quart nonreturnable bottle875252001002Nov 15
Old Fashioned Custard quart nonreturnable bottle875252000951Nov 15

These returnable glass bottles were distributed in Virginia, West Virginia, North Carolina, South Carolina, Georgia, Alabama, Ohio, Pennsylvania, Maryland, New Jersey, and New York in October through retail stores, direct delivery, and wholesale distributors. Shipments of this product started on October 15, 2020.

Eggnog and custard round, non-returnable glass bottles with the best by date of Nov 15 were distributed to The Fresh Market stores in Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Virginia. Shipments of this product started on October 14th, 2020.

The best by date of the bottle is located on the side of the bottle cap. No serious illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that product smelled like cleaning agent.

Consumers should return the bottles to the place of purchase for a full refund. The recall should be carried out to the user level. Consumers with questions may contact the company at 540-721-2045 Monday- Friday 8:00am-4:30pm Eastern Time.

* Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella

To date, the company has received no reports of illness or injury but is acting out of an abundance of caution to voluntarily recall any of the potentially affected product in the marketplace.

After initially certifying that this product had tested negative for Salmonella and was fit for human consumption, our supplier subsequently notified the company of the potential presence of Salmonella in specific lots of organic elderberries.

Consumers who may have purchased this product are advised to discontinue use immediately and discard or return the product for credit or refund. The recalled product is packaged in clear plastic bags weighing 4-ounces and bearing the “Natural Grocers” label. Only packages bearing the following pack dates are being recalled at this time: 20-216, 20-225, 20-246, 20-265, & 20-281.

UPC CodeDescriptionPacked on Dates
000082003043Org Whole Elderberries 4 oz20-216, 20-225, 20-246, 20-265 & 20-281

The product was distributed to 159 Natural Grocers stores located in Arkansas, Arizona, Colorado, Iowa, Idaho, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming. Consumers can find the specific locations of Natural Grocers’ stores in those states at: https://www.naturalgrocers.com/store-directoryExternal Link Disclaimer

Consumers with questions may contact the company by calling Customer Service at 303-986-4600, ext. 80801, Monday through Friday 8:00 a.m. to 5:00 p.m. (MST).


Company Contact Information

Consumers:Customer Service 303-986-4600, ext. 80801Media:Pamela Lipshitz plipshitz@naturalgrocers.com