Cosmetics Recalls
Sierra Stain Recalls Tattoo Pigments Because of Possible Health Risk
Sierra Stain LLC of Carson City, Nevada is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. Commonly reported symptoms of tattoo ink associated infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Symptoms can be difficult to recognize, as other conditions (e.g. allergic reactions) may also present with similar findings.
Dietary Supplements Recalls
Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
FOR IMMEDIATE RELEASE – 8/14/24 – Sacramento CA, Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters packaged in a carton to the consumer level. Boulla LLC was notified by Amazon that the product was found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil cannot be marketed as dietary supplements. Boom Max is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. To date, Boulla LLC has not received any reports of adverse events related to this recall.
Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil
FOR IMMEDIATE RELEASE – 8/14/24 – Sacramento CA, Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count blisters in a cardboard carton to the consumer level. Veata LLC was notified by Amazon that the products were found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil cannot be marketed as dietary supplements. Endurance Pro capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. To date, Veata LLC has not received any reports of adverse events related to this recall.
Food & Beverage Recalls
Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth
The product is packaged in a MONTREAL FUDGE gable box, Chocolate Fudge with nuts 5.6 Oz marked with the lot 0241500805 with expiration date of 2025/MR/01, lot 0241690105 with expiration date of 2025/MR/17, and lot 0241690205 with expiration date of 2025/MR/17, on the back of the box. No other products are impacted by this recall.
No illnesses have been reported to date in connection with this problem.
Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk
A previous press release was issued 08/19/2024. This updated press release includes information on the addition of Gutierrez brand ground cinnamon to the recall.
Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects. No illnesses have been reported to date in connection with this problem.
El Servidor Corp ground cinnamon was distributed to retail stores in New York starting on January 14, 2024.
Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins
Sunco & Frenchie LLC of Pine Brook, New Jersey is recalling its 10oz Terrafina Golden Raisins because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
Terrafina Golden Raisins were distributed in New York through retail stores by distributor Smith Valley Foods, LLC.
The product comes in a 10-ounce, clear plastic square-shaped container with bright orange labeling on the front. The back of the product is marked with Best If Used By 08/2025, Lot#GRA240602 and Best If Used By 05/2025, Lot# GDR240901. The UPC is 847938001385. The back of the product indicates the product is distributed by Smith Valley Foods LLC.
Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks
Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclared milk and/or sesame were discovered during the FDA review of the product labels. People who have an allergy or severe sensitivity to milk and sesame run the risk of serious or life-threatening allergic reaction if they consume these products., which is not listed as an ingredient on the label.
The recalled snacks were distributed nationwide via retail stores, through online orders at www.bliss-tree.us and through Amazon (www.amazon.com)
Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops
FOR IMMEDIATE RELEASE – Englewood Cliffs, New Jersey – August 21, 2024 - Unilever in the United States is recalling approximately 137,000 cases of Popsicle Jolly Rancher Frozen Confection Pop products (single serve offerings) because the products may contain milk, which is not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.
The only impacted products are Popsicle Jolly Rancher Frozen Confection Pop single-serve products which are marked for individual sale. These products are typically sold through channels such as ice cream trucks, concession stands, and grab-and-go freezers throughout the United States. This recall does not apply to the 18-count Popsicle Jolly Rancher multi-pack products that are sold in grocery stores and retailers nationwide.
El Chilar HF, LLC. Expands Recall of El Chilar Ground Cinnamon Due to Elevated Levels of Lead
El Chilar HF, LLC on 03/06/2024 issued a recall of Lots # D-300 EX1024 and F272 EX1026, contained in 127 boxes (12 bags/box) of El Chilar “Cinnamon Ground” (1.25 oz bag), because it may contain traces of lead. Further investigation indicates that the issue could be caused by a potentially adulterated raw material from the supplier.
While lead can affect almost all body systems, its effects depend on the amount and duration of lead exposure and age/body weight. If a child is exposed to enough lead for a protracted period (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects. Lead can cause serious health problems if too much is ingested, such as damage to the brain and kidneys and can interfere with the production of red blood cells that carry oxygen to all parts of your body.
The Maryland Department of Health (MDH) collected samples in February 2024 from Lot: E-054, EX 0225 and D-181, EX 0624 El Chilar Ground Cinnamon, which tested high in lead. These additional lots of El Chilar Ground Cinnamon have been added to the original recall.
Flagstone Foods, LLC. Allergy Alert on Undeclared Peanuts, Almonds and Pecan in Emerald Kettle Glazed Walnuts
FOR IMMEDIATE RELEASE – 16Aug 2024. – Flagstone Foods, LLC., manufacturer of Emerald Nuts, is issuing a voluntary recall of 6.5oz Emerald Kettle Glazed Walnut lot 2EE06284 because packages contain undeclared Peanuts, Almonds and Pecans. People who have an allergy or severe sensitivity to Peanuts, Almonds, and Pecans run the risk of serious or life-threatening allergic reactions if they consume or are exposed to the product.
The product was distributed to Publix locations in Florida, Alabama, and Georgia. Consumers have identified the mislabeled product in the state of Florida
Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk
Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects. No illnesses have been reported to date in connection with this problem.
El Servidor Corp ground cinnamon was distributed to retail stores in New York starting on January 14, 2024.
Medical Devices Recalls
Tandem Diabetes Care Provides Update on March 2024 Nationwide Recall of t:connect Mobile App for iOS Devices
SAN DIEGO – August 12, 2024 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience following the release of version 2.7.1 of the app in March. Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release.
Under-delivery of insulin because of a pump shutdown can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin. There have been 107 confirmed adverse events with this recall. Adverse events are defined as a confirmed high blood sugar and/or an event requiring medical intervention. Two hospitalizations and no deaths have been reported.
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