FDA Registration Assistance Blog

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 … Continue reading “Rojas Inc. Recalls Plain Dried Salted Plums Because of Possible Health Risk”

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 … Continue reading “El Super Leon Ponchin Snacks Inc Recalls Saladitos Dry Salted Plums Because of Possible Health Risk”

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 … Continue reading “SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’”

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 … Continue reading “La Fiesta Food Products Recalls Saladitos Salted Plums with Chili Because of Possible Health Risk”

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 … Continue reading “Golden Medal Mushroom Inc. Recalls Enoki Mushrooms Because of Possible Health Risk”

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 … Continue reading “Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil”

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 … Continue reading “A&E Corrales LLC Recalls Saladitos Dried Salted Plums with Chili Because of Possible Health Risk”

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 … Continue reading “Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations”

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 … Continue reading “The Royal Ice Cream Company, Inc. Recalls Batch Ice Cream Brand Vanilla, Ginger, and Mocha Chip Ice Cream Because of Possible Health Risk”

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 … Continue reading “El Chavito, Inc. Recalls Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums with Chili Because of Possible Health Risk”