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Alerts, Food Recalls & Health News

The following Food Safety Alerts & Tips comes from FoodSafety.gov.  It includes food safety tips and recall alerts.  Please refer to  FoodSafety.gov http://foodsafety.gov for more information.

For information from MedWatch.com, The FDA Safety Information and Adverse Event Reporting Program please scroll toward the bottom of this page.

Food Recalls, Alerts & FDA Health News

• 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
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• UPDATED: CORRECT PRODUCTION CODE INFORMATION Diamond Pet Foods Expands Voluntary Recall of Dry Pet Food Due to Potential Salmonella Contamination

  Diamond Pet Foods today announced that it is expanding a voluntary recall to include batches of nine brands of dry pet food formulas manufactured between December 9, 2011 and April 7, 2012 due to potential Salmonella contamination. In April 2012, Diamond Pet Foods initiated three voluntary recalls of Diamond manufactured dry dog food.
  
  

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Medicine-Medical Device Recalls Alerts, & MedWatch News

• Zithromax (azithromycin): FDA Statement on risk of cardiovascular death

  A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug
  
  

• Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

  UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients.
  
  

• Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume

  An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.
  
  

• Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies

  UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid.
  
  

• Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians

  [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
  
  

• Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions

  UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012
  
  

• X-Rock: Recall - Undeclared Drug Ingredient

  Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
  
  

• Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result

  Customers should immediately discontinue use of any affected product.
  
  

• Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

  [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
  
  

• Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication

  Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.
  
  

• Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination

  Exposure to contaminated product may lead to serious infections.
  
  

• Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

  Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.
  
  

• Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

  Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
  
  

• Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform

  May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
  
  

• Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

  The counterfeit product may have resulted in patients not receiving needed therapy.
  
  

• Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

  Revised drug label clarifying dosing and warning recommendations.
  
  

• Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates

  Risk of embolization/infarction to organs and potential organ complications.
  
  

• Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury

  Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.
  
  

• Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly

  Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient.
  
  

• Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor

  Reports of gastrointestinal complaints.
  
  

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