Food and Drug Administration--Recalls/Safety Alerts

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix (Fri, 18 May 2018 20:31:00 -0400) Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens and this is not declared on the package. Individuals who have an allergy or severe sensitivity to milk, soy, wheat or cashews run the risk of serious or life-threatening allergic reaction if they consume these products

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk (Fri, 18 May 2018 20:00:00 -0400) Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarriages, stillbirths, and fetal infection in pregnant women. People experiencing these problems should seek immediate medical attention.

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls (Fri, 18 May 2018 14:19:00 -0400) MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil (Thu, 17 May 2018 16:52:00 -0400) Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

BLM Issues Allergy Alert On Undeclared Egg and Milk (Thu, 17 May 2018 13:04:00 -0400) BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato (Wed, 16 May 2018 17:22:00 -0400) Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it 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.

Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency (Mon, 14 May 2018 18:39:00 -0400) Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.

Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product (Fri, 11 May 2018 21:02:00 -0400) Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement) (Wed, 09 May 2018 10:04:00 -0400) FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Piperacillin and Tazobactam For Injection 3.375 Grams Per Vial, Due to Presence of Glass Particulates (Mon, 07 May 2018 13:53:00 -0400) East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Ampicillin and Sulbactam For Injection USP 3 Grams Due to The Presence of Visible Particulate Matter (Mon, 07 May 2018 13:21:00 -0400) AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk (Fri, 04 May 2018 17:26:00 -0400) Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination (Thu, 03 May 2018 21:59:00 -0400) Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

Voluntary Recall of Certain Golden Flake, Good Health, UTZ and Weis Brand Tortilla Chips Because of Possible Milk Allergen (Thu, 03 May 2018 11:28:00 -0400) Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Seabear Company Issues a Voluntary Recall of Cold Smoked Wild Coho Salmon Lox Because of Possible Health Risk (Tue, 01 May 2018 21:59:00 -0400) Seabear Company of Anacortes, Washington is voluntarily recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand, affected lot # CSCO-17339, Pack Date 17-340, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg (Mon, 30 Apr 2018 17:38:00 -0400) Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

UPDATED: Van’s Foods Voluntarily Recalls Gluten Free Waffles Due to Gluten, Undeclared Wheat & Undeclared Milk (Sun, 29 Apr 2018 08:26:00 -0400) Van’s Foods is voluntarily recalling Van’s Gluten Free Waffles with a lot code date of #A640234710–WL2, BEST BY AUG 22, 2018 and UPC 0 89947 30206 4. The products are being recalled because a limited number of the wrong packaging were used during the production of Van’s Belgian Waffles. The product inadvertently packaged in the Van’s Gluten Free Waffle box contains gluten, undeclared wheat and undeclared milk. People who have an allergy or severe sensitivity to milk, wheat or gluten run the risk of serious or life-threatening allergic reaction if they consume these products. These products could also cause a serious autoimmune reaction to people with celiac disease if consumed.

Ethnic Foods Inc. Issues Allergy Alert on Undeclared Peanuts in “Bhavnagri Mix” (Fri, 27 Apr 2018 11:22:00 -0400) Ethnic Foods Inc. of 76 South Bayles Avenue, Port Washington, NY 11050, is recalling its 19 ounce package of Bhavnagri Mix snack mix because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Greenbelt Greenhouse Ltd Recalls Greenbelt Microgreens Brand Microgreens Because of Possible Health Risk (Wed, 25 Apr 2018 21:14:00 -0400) Greenbelt Greenhouse LTD of British Columbia, Canada is recalling all Greenbelt Microgreen products with the best before dates from 4/24/18 and 4/31/18 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.

Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder (Tue, 24 Apr 2018 19:08:00 -0400) Labrada Nutrition of Houston, TX, is recalling specific lots of its "LeanPro8" Protein Powder because they may contain undeclared egg protein. People who have allergies to egg protein run the risk of serious or life-threatening allergic reaction if they consume these products.