Drug Recalls
Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil
FOR IMMEDIATE RELEASE – 2/10/22 – Wilmington DE, Positive-Health is voluntarily recalling lot number 48658908 with Expiry 9/9/23 of Rise Up Red Edition Capsules packaged in 10-count blisters packaged in a carton to the consumer level. Positive-Health was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil. an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Rise Up Red Edition makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil and Tadalafil
FOR IMMEDIATE RELEASE – 02/08/2022 - Brentwood, NY, Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023 of Red Mammoth capsules to the consumer level. Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, an ingredients known as a phosphodiesterase (PDE-5) inhibitors found in an FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Red Mammoth capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Your Favorite Shop Issues Voluntary Nationwide Recall of the Red Pill Capsules, Due to the Presence of Undeclared Tadalafil
FOR IMMEDIATE RELEASE – 2/8/2022 – Jackson, NJ – Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. Your Favorite Shop was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in The Red Pill makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take The Red Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules Due to the Presence of Undeclared Sildenafil and Tadalafil
FOR IMMEDIATE RELEASE – 2/8/22 – Monsey, NY, ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules, Lot 1230004, Exp 03/30/2024 and MAC DADDY PURPLE Capsules, Lot 1230005, Exp 03/30/2024 to the consumer level. ABC Sales 1 Inc was informed by Amazon that laboratory analysis found MAC DADDY RED capsules to be tainted with sildenafil and tadalafil and MAC DADDY PURPLE capsules to be tainted with tadalafil. Sildenafil and tadalafil are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in MAC DADDY capsules makes these products unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.
Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil
FOR IMMEDIATE RELEASE – 2/3/2022– Brooklyn, NY Junp LLC is voluntarily recalling Lot number 2010291, Exp Date: 01/07/2024 of MegMan Performance Booster capsules, packaged in 10-count blisters packaged in a carton to the consumer level. Junp LLC was notified by Amazon that laboratory analysis has found the product to be tainted with Tadalafil. Tadalafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in MegMan Performance Booster makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Food & Beverage Recalls
Concord Farms Recalls Enoki Mushrooms Due to Possible Health Risk
CONCORD FARMS of Vernon, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #045633 grown in Korea, because it has the potential to be contaminated with listeria monocytogenes, a bacterium which can cause life-threatening illness.
Symptoms of listeria may include fever, muscle aches, severe headache, nausea, vomiting, stiff neck, confusion, loss of balance, and convulsions. People experiencing these problems should seek immediate medical attention. This bacteria can be completely destroyed and the risk of infection can be eliminated by thoroughly cooking foods at temperatures of 165°F (73.8°C).
Lot #045633 was distributed from California to retail stores through produce distributors, while traces of the bacterium was discovered by CDPH sampling. Product is packaged in a bright blue and transparent plastic packaging, with the “fresh enoki mushrooms”. Enoki mushrooms are white, stringy with small caps. The weight of the product is 5.25 oz (150g). The UPC barcode numbers are 001958939091, with no other codes.
American Gourmet Recalls Saladitos Dry Salted Plums Because of Possible Health Risk
American Gourmet is recalling snack size bags of .99c Saladitos, net weight 1.5 oz, per picture below because it has the potential to be contaminated with 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.
Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. 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. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.
Product was distributed in South San Diego through Liquor stores. It has a lot # 211203 and a sell by 12/03/2022. The UPC number is #1578600104
Jan Fruits Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
February 8, 2022, Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has 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.
The recalled Enoki Mushroom product was distributed in CA to produce distributors or wholesalers for further distribution to retail stores.
The Enoki Mushroom comes in a 200g/7.05oz clear plastic package with the following description “Taiwan Best Quality Enoki Natural Mushroom***Manufacturer: Changhua County Mushrooms Production Cooperative” and “Distributor Jan Fruits Inc.” in English. There is a green lettered “Premium” Printed with two QR scan codes and UPC 8 51084 00835 8 on the back side of a package. There is no lot code or dates on a package.
Rojas Inc. Recalls Plain Dried Salted Plums Because of Possible Health Risk
02/06/22, Rojas Inc., Los Angeles, CA is recalling PLAIN DRIED SALTED PLUMS in 0.5oz packages because it has the potential to have elevated levels of 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. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
The distribution of the affected product was limited to Southern California.
El Super Leon Ponchin Snacks Inc Recalls Saladitos Dry Salted Plums Because of Possible Health Risk
El Super Leon Ponchin Snacks Inc of San Diego, CA (February 3rd, 2022) is recalling Saladitos Dry Salted Plums with and without Chili, El Leoncito and El Super Leon brands, because it has the potential to be contaminated with 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. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. 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. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.
Products were distributed in California to different retails stores, grocery stores, convenience stores, and cash & carry stores. Products are packaged in plastic peg bags and usually sold near the registers at the stores. All of the lot codes for the product are included in the recall of Saladitos.
The affected products are sold under brands El Leoncito and El Super Leon and each package has a net weight of 1.05oz, 1.4oz, and 16oz. The Dry Salted Plum product is packaged with a green top packaging and the Dry Salted Plum with Chili and chamoy is packaged with red top packaging.
A&E Corrales LLC Recalls Saladitos Dried Salted Plums with Chili Because of Possible Health Risk
On February 3, 2022, A&E Corrales LLC, Seattle, WA is recalling Saladitos Dried Salted Plums With Chili because it has the potential to be contaminated with 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. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. 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. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.
The affected product was distributed nationwide through distributors to retail stores, and online orders on Amazon and company website at spiceandchili.wazala.com from August 1, 2021 to December 31, 2021.
The impacted Saladitos Dried Salted Plums With Chili product has net weight of 16 oz (1 lb) with UPC # 0661799748162.
La Fiesta Food Products Recalls Saladitos Salted Plums with Chili Because of Possible Health Risk
La Fiesta Food Products, La Mirada California is recalling all lots of Saladitos Con Chile(Salted Plums with Chili) because it has the potential to be contaminated with 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. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. 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. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.
The affected product was distributed in California as well as Nevada, North Carolina, and Georgia through distributors to retail stores from December 1, 2021 through January 31, 2022.
The impacted Saladitos Con Cr le(Salted Plums with Chili) products are identified below.
La Fiesta Brand Saladitos Con Chile(Salted Plums with Chili)
UPC#032327028290
The Royal Ice Cream Company, Inc. Recalls Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream Because of Possible Health Risk
The Royal Ice Cream Company, Inc. of Manchester, CT is recalling specific lots of Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream, because it has 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.
The effected ice cream was distributed to Market Baskets in Mass, Big Y Stores in MA. and CT & Roach Brothers Markets in MA.
The products are packaged in paper 16oz pints with the Batch Ice Cream brand name and flavors clearly shown on the front. Products are coded with the Date of Manufacture as 1/19/22 and Best By: 7/19/23, found on the bottom of the cup. UPC Vanilla – 837654968505 Ginger- 83765496856- Mocha chip 83765496853
Golden Medal Mushroom Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Golden Medal Mushroom Inc. of Los Angeles, CA is recalling all cases of its 200g/7.05-ounce packages of Enoki Mushrooms, lot # 300511, product of China, because it has 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.
The recalled Enoki Mushroom has the lot # 300511. Product was distributed directly in Chicago, IL in January 2022, and it has been further distributed to retail stores nationwide.
The Enoki mushroom was packaged in a 200g/7.05ounces and has the UPC 6 953150 100684. Product is packaged in a vacuum sealed plastic package with upper transparent and lower portion has a black background. The product is “Product of China” and there is no English translation on label. There are no business name & address printed on packages.
El Chavito, Inc. Recalls Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums with Chili Because of Possible Health Risk
EL CHAVITO, INC. of San Diego, CA is recalling all lots of Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With Chili because it has the potential to be contaminated with lead. This recall does not impact any other El Chavito brand products.
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. Exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.
Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. 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. A child with lead poisoning may not look or act sick. Lead poising in children can cause: learning disabilities, developmental delays, and lower IQ scores.
The affected product was distributed nationwide through distributors to retail stores, and online orders on El Chavito website from 01/09/2019 to 02/02/2022.
Medical Device Recalls
Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations
CHICAGO, February 4, 2022—In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305.
There is a potential issue with bellavista™ 1000 and 1000e ventilators that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the Data Communication port set to “HL7”. Customers with software version 6.0.1600.0 or higher installed have been notified by Vyaire to immediately disable the HL7 data communication if activated. If the HL7 data communication is not disabled, such devices are at risk of the reported unintentional ceasing of ventilation.
SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’
January 31, 2022. SD Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution or use in the United States. While there is no known distribution of these tests directly to consumers, SD Biosensor, Inc. is issuing this voluntary recall out of an abundance of caution.
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