Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration.
Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
The chemical NDMA is considered a possible carcinogen by the US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.
NDMA has also been found in certain blood pressure drugs and antacid.
This is the latest in a series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.
Nostrum said it has not received any reports of adverse events related to the recall. The company also said it was notifying its distributors and arranging for the return of the recalled product.
The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”
More than 34 million people in the US have diabetes — about 1 in 10 — with approximately 90 to 95% of them being diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention.
CNN’s Hollie Silverman contributed to this report.
The product was distributed in Colorado, Kansas, South Dakota, Wyoming and New Mexico
FDA said egg was listed as one of the ingredients of the ranch dressing but it was not mentioned on its label
No adverse reactions related to the recalled product have been reported
Minnesota-based Russ Davis Wholesale is recalling its Mixed Veggie Cup with Dip due to “undeclared egg” content in it. People with egg allergy may experience an allergic reaction if they consume the product, the company warns.
The issue was reportedly discovered during a routine label audit when the company’s quality control team noted that egg was listed as one of the ingredients of the ranch dressing but it was not mentioned on the label.
“The Mixed Veggie Cup with Dip was distributed in Colorado, Kansas, South Dakota, Wyoming, New Mexico in higher education, health care and corporate campus’ in grab ‘n go coolers,” the Food and Drug Administration (FDA) announced Thursday.
The affected products are labeled as J&O Mixed Veggie Cup with Dip in 5.o-ounce plastic containers with a sell-by date from Sept. 30 to Nov. 2, 2020.
No adverse reactions related to the recalled products have been reported so far but the company warns of possible “serious” or “life-threatening” allergic reactions in people who are sensitive to eggs if they consume the product. It has asked those who have purchased the product to dispose of it.
Customers who have any questions related to the recall can contact the company at 877-433-2173.
According to the American College of Allergy, Asthma & Immunology (ACAAI), egg allergy is actually one of the most common allergies, especially in children. People who are allergic to chicken eggs may also be allergic to other types of eggs including quail and turkey.
“Experts estimate that as many as 2% of children are allergic to eggs,” the ACAAI noted. “Fortunately, studies show that about 70% of children with an egg allergy will outgrow the condition by age 16.”
Common symptoms of egg allergy include skin reactions such as hives, difficulty in breathing, sneezing or runny nose, watery eyes, or stomach pain after eating or even just by touching eggs. A less common but life-threatening reaction is anaphylaxis, which requires immediate medical treatment.
Although egg allergy is quite common, it is an ingredient that usually remains hidden in products. This is why the FDA lists it as one of the eight allergens to be included on the ingredients label of packaged food products “in clear language”.
Pictured: A salad with fresh baby gem lettuce, heirloom tomato, toasted walnuts, and miso yaki tofu dressingPhoto: Getty Images/Guillem Sartorio
E.Coli, metal and even a dead bat has have been found in recalled food. In fact, food recalls are increasing. Yet, that might actually be a good sign. Here’s why.
Frozen fish sold at Trader Joe’s stores in 19 states is being recalled because it contains wheat and milk, which were not listed on the label.
In a recall notice posted on the Food and Drug Administration website, supplier Orca Bay Foods of Seattle, Washington said the recall is for 4,450 pounds of boxes of 10-ounce boxes of Trader Joe’s brand Gluten Free Battered Halibut because of the undeclared allergens.
No illnesses or allergic reactions have been reported to date, Trader Joe’s said in a statement on its website, noting all of the affected product “has been removed from sale and destroyed.”
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The recalled halibut has code 537312620 and a “best if used by” date of Nov. 5, 2021 at the end of the box. The product SKU is 00503822.
The fish was sold in Trader Joe’s stores in Connecticut, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New York, Ohio, Rhode Island, Tennessee, Vermont and Wisconsin, according to the recall notice.
Trader Joe’s says customers with an allergy or sensitivity to wheat or milk should not eat the fish. “We urge you to discard the product or return it to any Trader Joe’s for a full refund,” the grocer said.
Orca Bay Foods said in its notice that people with an allergy “or severe sensitivity to wheat and milk run the risk of serious or life-threatening allergic reaction if they consume this product.”
Trader Joe’s says customers with questions contact Trader Joe’s Customer Relations at 626-599-3817 weekdays from 6 a.m. to 6 p.m. PT or can fill out a form on the website.
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Trader Joe’s is pulling its Gluten Free Battered Halibut off shelves after discovering undeclared wheat and milk in the product.
The popular grocery store issued a recall notice on its website for 10 oz. boxes of halibut that were packaged with the SKU# 50382 and the product code 537312620. The affected product from supplier Orca Bay Foods, LLC had a “best if used by” date of November 5, 2021 and was sold in 19 states (see a full list here) including New Hampshire, Kansas, Kentucky, New York, Massachusetts and Maine.
No illnesses or allergic reactions have been reported so far, but Trader Joe’s encouraged shoppers who recently purchased the product to proceed with caution if they have a wheat or milk allergy or sensitivity.
“We urge you to discard the product or return it to any Trader Joe’s for a full refund,” the company wrote.
According to a separate recall notice on the U.S. Food & Drug Administration’s website, the recall “was initiated after it was discovered that product containing Wheat and Milk was distributed in packaging that did not reveal the presence of the allergens.”
Failure to properly label these ingredients can cause big problems for those who try to avoid them for dietary or medical reasons.
“People who have an allergy or severe sensitivity to wheat and milk run the risk of serious or life-threatening allergic reaction if they consume this product,” the notice reads.
Following this discovery, Trader Joe’s and Orca Bay Foods removed all of the affected product from sale and destroyed 4,450 lb. (356 cases) of the frozen fish.
Have questions on the recall? Trader Joe’s encouraged customers to contact them at (626) 599-3817 or Orca at 1-800-932-ORCA.
Orca Bay Foods is recalling its Trader Joe’s brand Gluten Free Battered Halibut
The recall was issued after the discovery of undeclared milk and wheat allergens
Although less common, anaphylaxis is a potentially life-threatening reaction to allergens
Trader Joe’s is recalling 4,450 pounds of its Gluten Free Battered Halibut due to undeclared allergens. Those with wheat or milk allergies may potentially experience severe allergic reactions if they consume the product.
Seattle-based Orca Bay Foods on Friday recalled 356 cases of its 10-ounce Trader Joe’s brand Gluten Free Battered Halibut SKU 00503822 with the code 537312620 and “Best If Used By Nov. 5, 2021” noted on the box.
In an announcement posted on the U.S. Food and Drug Administration (FDA) website, Orca Bay Foods noted that the affected products contain wheat and milk allergens that were not declared in the packaging information. The recall was initiated once this was discovered.
The affected products were sold in Trader Joe’s stores in Wisconsin, Vermont, Tennessee, Rhode Island, Ohio, New York, New Hampshire, Nebraska, Missouri, Minnesota, Michigan, Massachusetts, Maine, Kentucky, Kansas, Iowa, Indiana, Illinois and Connecticut.
Those who may have purchased the product are being advised to check if the item they bought is affected by the recall. If it is, they should return it to where they bought it for a full refund.
Photos of the recalled product are available at the FDA website.
Pictured: Representative image of a plate of fish.Photo: Monika Schröder/Pixabay
So far, no illnesses related to the recall have been reported but the company said in the announcement that people with an allergy or “severe sensitivity” to wheat or milk may experience a severe allergic reaction if they consume the product.
In the case of wheat allergy, symptoms such as swelling, hives, nasal congestion, headache and difficulty in breathing may appear within minutes to hours after consuming products that contain wheat. In severe cases, the patient may even experience anaphylaxis, which is a less common but potentially life-threatening allergic reaction that may cause the throat to swell and send the body into shock, according to the American College of Allergy, Asthma & Immunology (ACAAI).
What’s difficult about wheat allergy is that it’s not always obvious whether a product contains wheat. Although breads, pastas and cereals are the more obvious food products that contain wheat, the grain may also be present in hot dogs, ice cream or sauces. Even non-food items such as Play-Doh and cosmetics may contain wheat.
“A wheat allergy reaction can cause symptoms that range from mild to life-threatening; the severity of each reaction is unpredictable,” the ACAAI said.
As such, it’s important for people with food allergies in general to always carry an auto-injector with epinephrine in case of an anaphylactoc shock.
Similarly, people with milk allergy may also experience more common symptoms such as hives, stomach upset, bloody stool and vomiting, with anaphylaxis being a rarer reaction.
The ACAAI notes that about 80% of children outgrow their milk allergy