Archive for the ‘Food & Drug Recalls’ category

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

October 29, 2018

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research […]

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

October 29, 2018

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

October 29, 2018

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing […]

Urgent: Curry Spice Recall

October 25, 2018

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead. Read The Complete Story!

UBC Food Distributors Recalls Hot Curry Powder and Curry Powder due to Lead

October 25, 2018

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

October 24, 2018

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of “Chocolate Whoopie Pie” because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

October 24, 2018

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

October 24, 2018

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices

October 24, 2018

Sirob Imports, Inc of Lindenhurst, NY is recalling, Corrado, Orlando Imports, Nouri’s Syrian Bakery, Mediterranean Specialty Foods Brand and Butera Fruit Market Curry Powder because it contains elevated levels of lead.

FDA approves new drug to treat influenza

October 24, 2018

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

October 24, 2018

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

October 23, 2018

A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products

FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids

October 23, 2018

FDA warns website networks as part of global crack down for selling illegal pharmaceuticals

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

October 23, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

October 23, 2018

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

October 22, 2018

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

October 22, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

October 19, 2018

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, 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, […]

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

October 19, 2018

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (soy). People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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