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Food and Drug Administration--Recalls/Safety Alerts

Recall Information from FDA
  1. Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Products Due to a Potential Lack of Sterility Assurance
    Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance.
  2. H-E-B Issues Recall for Undeclared Allergen. H-E-B Creamy Creations Cherry Vanilla Light Churn Style Ice Cream Being Recalled From Five Stores For Undeclared Allergen
    H-E-B, committed to the quality of its products, is issuing a recall for H-E-B Creamy Creations Cherry Vanilla Light Churn Style Half-Gallon Ice Cream from five potentially impacted stores because it may contain an undeclared nut allergen. There have been no reported illnesses related to this recall.
  3. JFC International Inc. Issues Missing English Label and Allergy Alert on Undeclared Wheat, Soybean, and Fish (Bonito) in Futaba Sesame Hijiki Rice Seasoning
    JFC International Inc. of Los Angeles, CA is voluntarily recalling a rice seasoning product because it was found to be missing the English Product Label for sale in the United States. In addition, due to the missing English label, the product has undeclared Wheat, Soybean, and Fish (Bonito) allergens. People who have allergies to wheat, soybeans, or fish (bonito) run the risk of a serious life-threatening allergic reaction if they consume the product. No illnesses have been reported to date in connection with this problem.
  4. United Natural Trading LLC Announces Voluntary Recall of Products Containing Organic and Natural Chopped Dates Due to Possible Health Risk
    United Natural Trading LLC, Edison, NJ, is voluntarily recalling a limited number of products containing Organic and Natural dates (see below) and sold under the Nature’s Promise, Woodstock, Market Basket, and Wholesome Pantry brands due to a possible health risk from Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune symptoms.
  5. Batch of Fat Cat Purry-Purry Sauce Hot Sauce Recalled Due to Undeclared Allergens in Per-Peri Pepper Ingredient
    A single production batch of Fat Cat Purry-Purry Sauce Hot Sauce, sold specifically to Winn-Dixie Supermarkets, BI-LO Supermarkets and Harvey’s Supermarkets in the Southeastern U.S., has been recalled due to a potential peanut contamination found in the product. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
  6. House of Thaller Recalls Selected Pine Nut Hummus Products Because of Possible Health Risk
    House of Thaller, a Knoxville Tennessee company, is voluntarily recalling selected 10 ounce packages of Hummus with Pine Nut Topping, because an ingredient supplier notified us that their ingredient has the potential to be contaminated with Listeria monocytogenes.
  7. Recall Expansion in New Jersey on Fewer than 650 units of Ava’s Brand Organic Roasted Unsalted Cashews and Organic Roasted Unsalted Almonds
    Hampton Farms is expanding its voluntary recall to include Ava’s Brand Organic Roasted Unsalted Cashews and Ava’s Brand Organic Roasted Unsalted Almonds distributed only in New Jersey. This is the result of a recall expansion from Hampton Farms’ supplier, Hudson Valley Foods, Inc. of Highland, NY advising Hampton Farms that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes.
  8. Kabir’s Bakery issues allergy alert on undeclared milk in “Kabir’s Bakery Cinnamon Twist” and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes.
    Kabir’s Bakery of Brooklyn, NY is recalling “Kabir’s Bakery Cinnamon Twist“ and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes, due to the presence of undeclared milk. Consumers who are allergic to milk run the risk of serious life threatening allergic reactions if they consume this product
  9. Rikki USA, Inc. Issues Allergy Alert on Undeclared Milk in Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce
    Rikki USA, Inc. of Redmond, WA is recalling Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce because it contains 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 these products.
  10. Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps for Potential Electrical Test Failure Code
    Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.
  11. Update to Voluntary Recall of Eliquis® (apixaban) 5 mg Tablets (#HN0063) - Recall to retail/dispensing level only
    On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall.
  12. United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination
    United Pet Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners’ private label brands. The recall involves the brands and products described below.
  13. Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance
    Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.
  14. Vitakraft Sun Seed Issues Voluntary Recall of Certain Rabbit and Macaw Diets Due To Listeria Monocytogenes
    Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling certain Sunseed Parrot Fruit & Vegetable diet and Sunseed SunSations Rabbit Food due to a potential Listeria monocytogenes contamination. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
  15. Chic-A-Peas, LLC Recalls Product Because of Possible Health Risk
    Chic-a-Peas, LLC is voluntarily recalling a limited number of Chic-a-Peas Baked Crunchy Chickpeas 2 oz. packages because the product 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.
  16. Willis Ocean Inc Issues Alert on Uneviscerated Scomber Fish
    Willis Ocean Inc., Brooklyn, NY, is recalling its “the duck” brand “frozen steamed scomber fish”, because the product was found to be uneviscerated. The steamed scomber fish were distributed nationwide through retail stores.
  17. NOW Health Group Inc. Expands Voluntary Recall of Ellyndale® Nutty Infusions™ Because of Possible Health Risk
    NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is expanding the voluntary recall of Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter -- Product Code E0541, Lot# 2124118, to include Roasted Almond Butter – Product Code E0545, Lot# 2124119, and Mango Chili Cashew Butter – Product Code E0542, Lot# 2125156. An FDA follow-up inspection of the Nutty Infusions supplier’s facility revealed these lots have 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.
  18. Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance
    Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
  19. Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency
    Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection which would lead to a lower dose being administered.
  20. New England Natural Bakers Issues Voluntary Recall Due to Possible Health Risk
    NEW ENGLAND NATURAL BAKERS of Greenfield MA, is issuing a voluntary recall, the company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.