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Health Resources : Recalls & Alerts

FDA Firm Recalls

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products
Ottogi America, Inc. announced today it is recalling below 21 items due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.
Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products
-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.
RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen
RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product.
Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen
Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.
Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil
Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.
Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.
Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Italian Subs Lunch Box Sandwiches Ham & Swiss Croissants And Lunch Box Sandwiches Ham & Cheese Due To Possible Listeria Monocytogenes Contamination
– Grand Strand Sandwich is recalling Lunch Box Italian Subs, Lunch Box Ham & Swiss Croissants and Lunch Box Ham & Cheese Frozen Wedges due to a potential contamination of Listeria Monocytogenes.
Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been reported to date.
Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g
Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.
Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz
Olde York Potato Chips of Brampton, Ontario is recalling Clancy's Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they 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 these products. No other lot codes and no other products are involved in this action.
Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds
Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.
Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver
Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.
Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot #233 Because of Possible Health Risk
Oskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, 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. 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.
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls
Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for 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.
Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk
Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes
Funky Chunky, LLC Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts
Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.
Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk
Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of 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 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.
Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips
On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

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FDA Consumer


Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children
Soothing children’s gums with prescription or over-the-counter (OTC) medications, homeopathic remedies or teething jewelry can be dangerous. Consider safer alternatives.
To Eat or Not to Eat: Decorative Products on Foods Can Be Unsafe
FDA knows that some non-edible decorative glitters and dusts are promoted for use on foods. But consumers need to be aware that these materials, in fact, may contain materials that should not be eaten. Here’s how to tell if such materials are edible or not.
Spilling the Beans: How Much Caffeine is Too Much?
In what foods is caffeine found? Can caffeine pose a danger to your health? This Consumer Update answers these and other key questions about caffeine.
When to Give Kids Medicine for Coughs and Colds
Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold or cough? The FDA has some advice and tips.
Manage Your Asthma: Know Your Triggers and Treatment Options
You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.
Now's a Good Time to Get Your Flu Vaccine
Early in the fall is the best time to get your annual flu vaccine. Find out why it's important to get one.
Xylitol and Your Dog: Danger, Paws Off
This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.
Nutrition Facts Label Reboot: A Tale of Two Labels
The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize that both provide helpful information for consumers, delineate the differences between the two, and explain the scientific reason for making a change.
7 Tips for Cleaning Fruits, Vegetables
Fresh produce can become contaminated in many ways, but following these simple steps can help protect you and your family from foodborne illness.
The Facts on Tampons—and How to Use Them Safely
Tampons are medical devices regulated by the U.S. Food and Drug Administration. And if you or a loved one uses them, it's important to use them safely. Learn the basics and consider this advice.
The FDA Encourages New Treatments for Sickle Cell Disease
The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).
Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round
Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.
Medical Devices that Treat Obesity: What to Know
Obesity has been linked to many health problems, including heart disease, diabetes, and high blood pressure. Treatments for obesity range from healthy eating and exercise to prescription medicine and surgery. In recent years, FDA-regulated medical devices have also played a treatment role. Learn about approved products.
Ticks and Lyme Disease: Symptoms, Treatment, and Prevention
Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?
5 Tips for a Healthy Vacation
As you plan your next beach vacation, make sure your trip is a healthy one. Consider these five tips on sun safety, medications, contact lenses, tattoos, and eating well.
'Gluten-Free' Means What It Says
The only way to manage celiac disease is to avoid eating foods containing gluten. Learn how FDA's definition of 'gluten free' on food labels makes that possible.
Medication Safety: Advice for New Parents
Mother's Day and Father's Day are exciting for new parents. But moms and dads of babies 12 months and younger can also have some worries. Medical officers at the U.S. Food and Drug Administration offer health suggestions.
What to Know When Buying or Using a Breast Pump
Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. They can be used to extract milk, maintain or increase a woman's milk supply, and relieve engorged breasts (among other indications). But, to protect mothers and their babies, there are important safety considerations to know before using one.
How Many Calories? Keep an Eye on the Menu
FDA's final rule on menu labeling gives consumers the information on calories they need to make informed food choices.
Do You Vape? See These Tips on How to Keep E-Liquids Away from Children
Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.