Drug Recalls
Recall Expansion of Durisan Non-Alcohol Hand Sanitizer
Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary recall of Durisan Non Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Burkholderia contaminans, generally considered to be of low virulence, can range from no reaction to possible infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems.
In the April 10, 2021 announcement, Durisan expanded the recall to include all of its Hand Sanitizer products that had not expired (produced after 4/10/2019).
Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol
Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of Medically Minded hand sanitizers, lot numbers: E212020 & E082020 Best Buy of 5/21/2022 to the user/consumer level. FDA analysis has found the product to contain methanol.
Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
Scentsational Soaps & Candles, Inc., has voluntarily expanded its April 27 recall of scented Hand Sanitizers to include three lots of Goose Creek HAND SANITIZER (NDC 75078-004) + Aloe and one lot of COCO TKO HAND SANITIZER in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. These products are listed in the table below. These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were sold on the Internet and distributed nationwide in the USA by Goose Creek Candles, LLC and Coconut Stand.
Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Recall of DIBAR Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)
Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed below in Table 1 and Label 1). Dibar is also voluntarily recalling 2 lots of ProtectoRx Hand Sanitizer packaged in 2oz (Lot Number LDHSN050720) and 16oz (Lot Number LDHSN050820) fluid ounce bottles, respectively, to the consumer level. (See products listed below in Table 2 and Label 2). These products are being recalled after testing conducted by our firm revealed the presence of methanol.
Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil
Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil. Tadalafil and sildenafil are drugs known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil and sildenafil in Poseidon Platinum 3500 makes it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.
Food & Beverage Recalls
Faribault Foods, Inc. Announces Extension of Voluntary Recall of a Limited Quantity of S&W Brand Organic Black Beans, and O Organic Brand Black Beans and O Organic Brand Chili Beans Due to Compromised Hermetic Seal
Faribault Foods, Inc. is voluntarily recalling 15 ounce cans of S&W Organic Black Beans, 15 ounce cans of O Organic Brand Black Beans and 15 ounce cans of O Organic Brand Chili Beans because the cans may have a compromised hermetic seal. The compromised hermetic seal may affect can integrity and may cause the cans to leak, bloat or allow bacteria to grow inside the product which could lead to serious illness. Clostridium botulinum poisoning in humans can begin from six hours to two weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness. Botulism poisoning can cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided.
The recalled products were distributed to the States of CA, WA, UT, OR, AZ, CO, AK, HI, TX, GA, and ID in retail stores.
BUBS Naturals of Encinitas, CA Is Voluntarily Recalling Certain Lots of Its MCT Oil Powder Product Due to Undeclared Milk
BUBS Naturals of Encinitas, CA is voluntarily recalling certain lots of its MCT Oil Powder product because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The BUBS Naturals MCT Oil Powder product comes in a 10.6-ounce gusset bag and was distributed through its online store, Amazon, and some grocery stores.
JOLLY TIME® Pop Corn Issues Allergy Alert on Undeclared Milk in Healthy Pop® Kettle Corn 100’s (4 count)
JOLLY TIME Pop Corn today issued a voluntary recall of select Healthy Pop® Kettle Corn 100’s (4 count) because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled bags.
The products covered by this recall have been regionally distributed to select retailers / warehouses in Arizona, California, Colorado, Idaho, Iowa, Kansas, Minnesota, Missouri, Montana, Nebraska, Nevada, Oregon, South Dakota, Utah, Wisconsin and Wyoming. JOLLY TIME Pop Corn did not distribute these recalled products to any other states.
Hi Tech Pharmaceuticals Issues Voluntary Recall on Lipodrene w/25mg Ephedra Extract Dietary Supplement Due to the Presence of 1,4-dimethylamylamine (DMAA)
Hi-Tech Pharmaceuticals. Inc. of Norcross, GA is recalling Lot # 001211197, Exp. 12/25 of Lipodrene w/25mg Ephedra Extract Dietary Supplement due to the presence of 1,4-dimethylamylamine (DMAA). The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as: Shortness of breath, Arrhythmias, Elevated blood pressure, Tightening in the chest, and Heart attack. ( https://www.fda.gov/food/dietary-supplement-products-ingredients/dmaa-products-marketed-dietary-supplements) Hi-Tech Pharmaceuticals, Inc. is conducting a continuing investigation on the problem.
The voluntary recall was the result of FDA analysis that showed the presence of 1,4-dimethylamylamine in one lot of Lipodrene. Customers who have purchased Lipodrene Lot # 001211197 are advised to stop using this lot of product immediately and return it to the place of purchase for a full refund. Lipodrene Lot # 001211197 was purchased by and distributed through wholesale and direct sales in the U.S. and Puerto Rico, and through online sales for both personal use and retail sales.
Sara Lee Frozen Bakery Issues Allergy Alert on Undeclared Peanuts in Pecan Pies
Sara Lee Frozen Bakery announced today the recall of specific lots of select Sara Lee, Chef Pierre and Devonshire pecan pies produced between March 4 and April 1, 2021, because the product may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume the product.
Product was distributed nationwide through food service distributors.
Dash Xclusive Issues Voluntary Nationwide Recall of Imperia Elita Vitaccino Coffee Due to the Presence of Undeclared Sibutramine and Fluoxetine
Glendale, California, Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease. Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber. The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.
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