Food and Drug Administration--Recalls/Safety Alerts

1. Gills Onions Voluntarily Recalls One Lot of Diced Red Onions Because of Possible Health Risk
   Gills Onions, LLC of Oxnard, CA is initiating a voluntary recall, 2,360 pounds, of diced red onions with lot code 51RDA1A2119 and use-by-dates May 14, 15 and 17, 2012 because it may be contaminated by Listeria monocytogenes. The product is beyond its use-by-date, no illnesses have been reported in connection with this recall, and no other Gills Onions product is affected by this recall.
2. Caribe Produce, LTD CO. Recalls Papaya Maradol, Caribena Brand Because Of Possible Health Risk
   Caribe Produce LTD Co. of McAllen, TX, is recalling 286 cases of Papaya Maradol, Caribeña Brand papayas packed in 35 lb. cartons marked with the brand “ Caribeña “ and “ Product of Mexico” stamped on the side. The papayas are sold individually, and each one bears a label which states “3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO
3. River Ranch Recalls Retail And Food Service Salads Because Of Possible Health Risk
   River Ranch Fresh Foods, LLC of Salinas, CA is initiating a voluntary recall of retail and foodservice bagged salads,because they have the potential of being contaminated with Listeria monocytogenes following routine random retail salad finished product tests conducted in the marketplace by the Food & Drug Administration.
4. WEST COAST NUTRITIONALS, LTD. Issues a Voluntary Worldwide/Nationwide Drug Recall of Products FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON due to Undeclared Tadalafil
   WEST COAST NUTRITIONALS, LTD is conducting a voluntary recalling all lots of FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON capsules to the consumer level. An FDA lab analysis of FIRMINITE distributed by West Coast Nutritionals was found to contain undeclared Tadalafil.
5. Santos Agency, Inc. voluntarily recalls Santos Brands Products for undeclared peanuts and wheat in California
   Santos Agency, Inc. has initiated a recall of Santos Brand products i.e. various kinds of flours, legumes and spices because they may contain undeclared peanuts and wheat.
6. Bakery El Monte Sinai Corp Announces Allergy Alert on Undeclared Eggs in Rainbow Cake
   Bakery El Monte Sinai Corp., located at 100 A North Franklin Street in Hempstead, New York 11550, is recalling rainbow cake because it may contain undeclared eggs.
7. Hospira Announces A Nationwide Voluntary Recall Of One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
   Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed.
8. Nestlé Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat Food Due to A Low Level of Thiamine (Vitamin B1)
   Nestlé Purina PetCare (NPP) is voluntarily recalling one specific lot of its Purina Veterinary Diets® OM Overweight Management canned cat food, available through veterinarians in the U.S. and Canada. This precautionary measure is being taken in response to one consumer complaint received by FDA.
9. Correction to Date Code in Natural Balance Pet Foods’ Voluntary Recall Dated May 4, 2012 Due to the Potential for Salmonella Contamination
   On May 4, 2012, Natural Balance Pet Foods announced a voluntary recall of certain dry pet food formulas manufactured by Diamond Pet Foods at their Gaston, South Carolina facility. Link to original press release: http://www.fda.gov/Safety/Recalls/ucm303042.htm
10. Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California
    Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
11. Jonlly Fruits Inc. Alerta De Alergia Por No Decrarar Alergenos En El Producto
    Jonlly Fruits Inc. de Bayamon PR, hace un llamado al cosumidor de sus productos Jonlly Fruit Y Natural Tropic; China, Acerola, Uva, Parcha, Frutas, Limón, Toronja, Guanabana, Guava Piña, China Light, Mandarina, China Zanahoria. Porque prodria contener un tipo de alergeno no declarado en la etiqueta, específicamente; Partilly Hydrogenated Coconut oil, Corn Syrup Solids, Sodium Caseinate (a Milk Derivative), Xanthan Gum, Mono-And Diglycerides, Dipotassium Phosphate, Contains 2% or less of Sodium Silicoaluminate and Soy Lecithin.
12. Jonlly Fruits Inc. Issues Allergy Alert On Undeclared Allergens In Several Products
    Jonlly Fruits Inc., Bayamón, PR, is alerting consumers about their brands Jonlly Fruit and Natural Tropic: China (Orange), Acerola (Wild Cherry), Uva (Grape), Parcha (Passion Fruit), Fruta (Fruit Punch), Limón (Lemon), Toronja (Grapefruit), Guava-Piña (Guava-Pineapple), Guanábana (Soursop), China Light (Orange Light), Mandarin (Mandarina), and China-Zanahoria (Orange-Carrot) because it may contain undeclared sodium caseinate (a milk derivative). People who are allergic or are severely sensitive to milk run the risk of a serious or a life-threatening allergic reaction if they consume these products.
13. Moon Fishery (India) Pvt. Ltd. Recalls Its "Tuna Strips" Product Of India "AA" Or "AAA" Grade Because Of Possible Health Risk
    Moon Fishery (India) Pvt. Ltd., the Manufacturer of the Yellow Fin Tuna Nakaochi Scrape that was recently recalled by a U.S. Distributor, is also recalling its 22 pound cases of "Tuna Strips" Product of India AA or AAA GRADE because they have 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. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
14. Solid Gold Health Products for Pets, Inc. Recalls Dog Food Because of Possible Salmonella Health Risk
    Solid Gold Health Products for Pets, Inc., El Cajon, California, announced a voluntary recall of one batch of WolfCub Large Breed Puppy Food and one batch of Solid Gold WolfKing Large Breed Adult Dog, both with a Best Before date of December 30, 2012, and an "X" in the 11th digit of the date code.
15. Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes
    Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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. Water Pik, Inc. Announces Product Exchange Program
    Water Pik, Inc., a leading developer, manufacturer and marketer of innovative personal healthcare products, will replace certain SinuSense™ Water Pulsator nasal irrigation devices it manufactured between May, 2010 and July, 2011. This program is being offered in response to consumer complaints that water being used in the Pulsator seeped into the battery compartment leading to battery corrosion, possible reservoir contamination and the need to prematurely replace batteries.
17. Apex Pet Foods Initiates Voluntary Recall of Dry Pet Food Due to the Potential for Salmonella No Pet or Human Illnesses have been Reported Associated With Apex Dog Food
    Apex Pet Foods announced today that it is issuing a voluntary recall of all dry dog food formulas manufactured on January 24, 2012. Although there have been no animal or human illnesses related to Apex Dog Food and the product has not tested positive for Salmonella, the company has voluntarily initiated this recall out of caution to ensure the health and safety of consumers and their pets.
18. Natural Balance Pet Foods Initiates Voluntary Recall of Certain Dry Pet Food Due to the Potential for Salmonella Contamination
    Natural Balance Pet Foods announced today that it is issuing a voluntary recall of certain dry pet food formulas manufactured by Diamond Pet Foods at their Gaston, South Carolina facility. Although there have been no animal illnesses reported and none of the products included in the recall has tested positive for Salmonella, the company has voluntarily initiated this recall as a precautionary measure.
19. UPDATED: CORRECT PRODUCTION CODE INFORMATION Canidae Pet Foods Initiates Voluntary Recall of Dry Pet Food Due to the Potential for Salmonella
    Canidae Pet Foods announced today that it is issuing a voluntary recall of certain dry pet food formulas manufactured between December 9, 2011, and January 31, 2012 at the Diamond Pet Food Gaston, South Carolina plant. Although there have been no animal or human illnesses related to Canidae Pet Food, and the product has not tested positive for Salmonella, the company has voluntarily initiated this recall out of caution to ensure the health and safety of consumers and their pets.
20. Wellpet LLC Voluntarily Recalls One Recipe Of Dry Dog Food Due To Salmonella At Diamond Pet Foods' Facility
    WellPet LLC announced a voluntary recall of one recipe of Wellness® dry dog food after being notified by Diamond Pet Foods regarding the presence of Salmonella in Diamond’s Gaston, South Carolina facility. All Wellness products are tested for Salmonella and all lots tested negative prior to shipping to customers.