FDA/USDA October RECALLS -UPDATES FOR PREVIOUS MONTHS ~ SAFETY ALERTS~ 2021


** Ajinomoto Foods North America Inc., a Hayward, Calif. establishment, is recalling approximately 33,567 pounds of raw, frozen chicken and vegetable potsticker products that may be contaminated with extraneous materials, specifically clear flexible and hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw, frozen chicken and vegetable potsticker items were produced on July 22, 2021. The following products are subject to recall [view the labels here]:

  • 4.2-lb. plastic bags containing “Ling Ling POTSTICKERS CHICKEN & VEGETABLE” with lot code 1911203 and a “BEST BUY” date of 22 OCT 2022 on the label.

The products subject to recall bear establishment number “P20069” printed on the back of the package. These items were shipped to distribution centers in California and Washington and from there sent to retailer locations.

The problem was discovered after the firm received consumer complaints reporting clear flexible and hard plastic in the chicken and vegetable potsticker products.

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 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.

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.

Members of the media with questions about the recall can contact Paul Taylor, Ajinomoto Foods North America, at (909) 477-4800 or email at at taylorp@ajiusa.com. Consumers with questions about the recall can contact Willis Hwang, Ajinomoto Foods North America, at (855) 742-5011  or email at customercare@ajinomotofoods.com

**

October 8, 2021

The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.

The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.

Recommendations for Consumers

  • Do not undergo any filler procedure with needle-free devices.
  • Do not buy or use lip or facial fillers sold directly to the public.
  • Do not inject yourself or others with lip and facial fillers using any device. FDA-approved dermal fillers are indicated for prescription use only.
  • If you experience any problems or are concerned after injection of lip or facial fillers using a needle-free device, seek care from a licensed health care provider.
  • Report any problems experienced after using needle-free devices for injection of fillers to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
  • If you are considering a filler procedure, talk to a licensed health care provider about the procedure using an FDA-approved dermal filler. Dermal filler procedures should only be performed by licensed health care providers. For more information, see the FDA’s webpage: Dermal Fillers (Soft Tissue Fillers).

Device Description

Needle-free injectors are handheld devices or “pens” that use high pressure to force substances, such as fillers, into the body. The substances loaded in the pens are typically sold separately.

Risks Associated with Needle-Free Devices Used to Inject Lip and Facial Fillers

The FDA is aware that needle-free devices, and lip and facial fillers for use with these devices, are sold online directly to the public, and their use is promoted on social media to increase lip volume, improve the appearance of wrinkles, change the shape of the nose, and other similar procedures.

The FDA has not evaluated the safety and effectiveness of needle-free devices for injection of any dermal filler. The FDA also has not approved the marketing of needle-free devices for injection of these products.

FDA-approved dermal fillers are intended for prescription use only and for use with a syringe with a needle or cannula (a small flexible tubing with a blunt tip that is inserted under the skin).

Needle-free injection devices for aesthetic purposes do not provide enough control over where the injected product is placed. Lip and facial filler products sold directly to consumers online may be contaminated with chemicals or infectious organisms.

Additional risks may include:

  • Bleeding or bruising
  • Infection with bacteria, fungus, or virus from the filler or needle-free device
  • Transmission of disease between people who use the same needle-free device
  • Blockage of a blood vessel, leading to tissue death (necrosis), blindness, or stroke
  • Scarring
  • Damage to eyes from the pressure of the needle-free device
  • Formation of lumps in the skin
  • Discoloration of the skin
  • Allergic reaction

Complications may require immediate medical attention by a licensed health care provider.

Some complications may not be reversible.

FDA Actions

The FDA is monitoring reports of adverse events associated with needle-free devices for injection of fillers and will update the public if significant new information becomes available.

Marketing of prescription medical devices for purchase without a prescription is prohibited and may be subject to civil or criminal penalties. The FDA continues to evaluate marketing of needle-free devices for injection of fillers and will take action, as necessary.

Reporting Problems with A Device

If you think you had a problem with needle-free devices for injection of fillers, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

**

** Oct. 8, 2021 – Nick’s Famous Bar-B-Q, a Nashville, Tenn., establishment, is recalling approximately 3,140 pounds of ready-to-eat (RTE) smoked pork barbecue products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen RTE hickory smoked pork barbecue products were produced on September 7, 2021 and September 8, 2021 and packaged on September 8, 2021. The following products are subject to recall [view the label here]:

  • 20-lb. boxes of “Nick’s FAMOUS Hickory Smoked Pork Bar-B-Q” with a case code of 23452 and a use by date of 09/2022.

The products subject to recall bear establishment number “EST. 17863” inside the USDA mark of inspection. These items were distributed to institutions, including school locations in North Carolina. While the product was distributed to schools, it resulted from a commercial sale and was not part of food provided by the USDA for the National School Lunch Program.            

The problem was discovered by FSIS during an assessment of the establishment’s production records.

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.  

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

FSIS is concerned that some product may be in institutions’ freezers. 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.

Media and consumers with questions regarding the recall can contact Patrick Lewis, co-owner of Nick’s Famous Bar-B-Q, at patrick.lewis@nicksfamousbarbq.com or Rich Dupont, co-owner of Nick’s Famous Bar-B-Q at rich.dupont@nicksfamousbarbq.com.  

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854) 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/.

** Crider Foods, a Stillmore, Ga., establishment, is recalling approximately 525,717 pounds of canned beef with gravy products that may be contaminated with unsafe levels of lead, due to a spice mix used from an outside supplier, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The canned beef with gravy product items were produced on October 22, 2020 and March 15, 2021 production dates. The following products are subject to recall [view the labels here]:    

  • 12-oz. cans of “Hargis House ROAST BEEF AND GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “Clover Valley FULLY COOKED ROAST BEEF WITH GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “Kroger ROAST BEEF WITH GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “Hostess ROAST BEEF WITH GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “Laura Lynn roast beef WITH GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “ARMOUR Roast Beef WITH GRAVY” with best buy dates of 10/22/2022 and 3/15/2023.
  • 12-oz. cans of “HARVEST CREEK Roast Beef with Gravy” with best buy dates of 10/22/2022 and 3/15/2023.

The products subject to recall bear establishment number “EST. 31812” on the can. These items were shipped to retail locations nationwide.                  

The problem was discovered during routine surveillance sampling conducted by a state partner. In-plant verification activities conducted by Crider Foods in conjunction with FSIS found that a spice mix used from an outside source contained unsafe levels of lead.

There have been no confirmed reports of adverse reactions due to consumption of these products.

FSIS is concerned that some product may be 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 list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact Mark Howell, President of Crider Inc., at mhowell@criderinc.com or (912) 536-1424. Members of the media with questions about the recall can contact Aaron Schoeneberger, Crider Inc., Director of Marketing at aschoeneberger@criderinc.com or (912) 562-9142.

** WHIPPANY, N.J., October 1, 2021 — Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.

The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo packs. The impacted products are:

  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Powder Spray
  • Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray
  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
  • Lotrimin® AF Athlete’s Foot Liquid Spray
  • Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
  • Tinactin® Jock Itch (JI) Powder Spray
  • Tinactin® Athlete’s Foot Deodorant Powder Spray
  • Tinactin® Athlete’s Foot Powder Spray
  • Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at: https://livewell.bayer.com/document/2011External Link Disclaimer.External Link Disclaimer

There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada and Mexico through a variety of retail channels.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers may request a refund by visiting www.lotrimin.comExternal Link Disclaimeror www.tinactin.com,External Link Disclaimerand may contact Bayer with questions by calling 1-866-360-3266, Monday-Friday between the hours of 8 a.m. and 8 p.m. Eastern Time. A photo of the product will be required to receive a refund. After taking your photo and completing the refund process, please discard the product appropriately. Consumers who have the products that are being recalled should stop using. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products.

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

** Greenhead Lobster Products of Bucksport, Maine is recalling 5,749 lbs. of frozen cooked lobster meat because of a potential contamination 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.

Products listed in the table below were distributed to Maine and New Hampshire who distributed nationwide through wholesale distributers.

The potential for contamination was noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes. It should be noted that no other Greenhead Lobster Products retail products are impacted by this recall. This recall has been initiated in abundance of caution due to the potential for contamination.

No illnesses have been reported to date in connection with this problem.

Consumers who have purchased products listed in the table are urged not to consume this product and to return it to the place of purchase for a full refund.

If you have any questions, please do not hesitate to call our customer service desk at (207) 367-0950 between the hours of 8:00 Am and 4:00 Pm Eastern Standard Time.

** October 1, 2021 — Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.

The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo packs. The impacted products are:

  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Powder Spray
  • Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray
  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
  • Lotrimin® AF Athlete’s Foot Liquid Spray
  • Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
  • Tinactin® Jock Itch (JI) Powder Spray
  • Tinactin® Athlete’s Foot Deodorant Powder Spray
  • Tinactin® Athlete’s Foot Powder Spray
  • Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at: https://livewell.bayer.com/document/2011External Link Disclaimer.External Link Disclaimer

There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada and Mexico through a variety of retail channels.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers may request a refund by visiting www.lotrimin.comExternal Link Disclaimeror www.tinactin.com,External Link Disclaimerand may contact Bayer with questions by calling 1-866-360-3266, Monday-Friday between the hours of 8 a.m. and 8 p.m. Eastern Time. A photo of the product will be required to receive a refund. After taking your photo and completing the refund process, please discard the product appropriately. Consumers who have the products that are being recalled should stop using. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products.

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

** Sept. 28, 2021 – Espi’s Sausage and Tocino Co., a Seattle, Wash. establishment, is recalling approximately 2,048 pounds of frozen ready-to-eat chicken and pork hot dog products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen ready-to-eat chicken and pork hot dog product was produced on May 19, 2021. The following products are subject to recall [view the labels here]:

  • 12-oz vacuum packed plastic packages containing “Argentina MIGHTY MEATY CHICKEN AND PORK HOTDOG JUMBO” and SELL BY 051922.

The products subject to recall bear establishment number “EST. P-17524” inside the USDA mark of inspection. These items were shipped to a distributor in California and further distributed to retail locations.

The problem was discovered by FSIS during an assessment of the establishment’s sampling records that indicated the firm received confirmation from their third-party lab that a product contact surface had returned positive for Listeria monocytogenes.

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.  

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

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.

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.

FSIS advises those at increased risk of foodborne illness to reheat hot dogs to a minimum internal temperature of 165°F or until steaming hot before eating, due to the threat of listeriosis. The only way to confirm that hot dogs are cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, https://www.fsis.usda.gov/safetempchart.

Media and consumers with questions regarding the recall can contact Ester Somintac, Plant Manager for Espi’s Sausage and Tocino Co., at (206) 722-3365 or espisfood@yahoo.com

** Espi’s Sausage and Tocino Co. Recalls Ready-to-Eat Chicken and Pork Hot Dog Products Due to Possible Listeria Contamination

Espi’s Sausage and Tocino Co., a Seattle, Wash. establishment, is recalling approximately 2,048 pounds of frozen ready-to-eat chicken and pork hot dog products that may be adulterated with Listeria monocytogenes.

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.