Tag Archives: RECALL

Product Recalls Decline Across All Industries in Q1 2019

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As previously reported by Food Industry Executive based on a report and press release from Stericycle Expert Solutions, recalls within the consumer products, automotive, pharmaceutical, medical device, and food and beverage industries were all down in the first quarter of 2019.  This is the first time since 2012 that recalls were down across all industries … Continue Reading

FDA Issues Initiation of Voluntary Recall Draft Guidance

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Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and … Continue Reading

Raw Turkey Pet Food Linked to Human Illness in Minnesota

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The Minnesota Department of Agriculture (MDA) has issued a recall notice for three lots of raw turkey pet food manufactured by Woody’s Pet Food Deli after linking a human case of Salmonella Reading infection to the product. The infected person served the recalled food to a pet, which also tested positive for Salmonella but a … Continue Reading

NGO Publishes Report on Food Safety

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The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies … Continue Reading

CDC Declares End to Latest E. Coli Outbreak Linked to Romaine

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As previously reported on this blog, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce. This latest outbreak, which began in the Fall 2018, is not related to the E.coli outbreak … Continue Reading

FDA and CDC Identify One Source of E. Coli Contaminated Romaine

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As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, … Continue Reading

FDA Publishes Q&A Guidance on Mandatory Food Recalls

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The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to … Continue Reading

FDA Issues First Ever Mandatory Recall Order for Kratom Products

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On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory … Continue Reading

FDA oversees destruction and recall of kratom products

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On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom … Continue Reading

Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

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As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and … Continue Reading

OIG Report Finds FDA Recall Process is Slow

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As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with … Continue Reading

Complimentary Webinar TODAY: Recall Refresher

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Complimentary Webinar TODAY:  Refresher on Food Recalls and Recall Protection Don’t miss out!  Join Keller and Heckman partners, Art Garrett and Leslie Krasny, for a complimentary refresher webinar on recalls and what you can do now to protect your company.  The webinar is today, July 21, at 12 – 1 pm Pacific (3 – 4 … Continue Reading

Recalls Revisited

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HHS OIG issues early alert criticizing FDA’s food recall procedures. Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall … Continue Reading

Tomato Toss

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Federal judge tosses final claim in tomato farm’s lawsuit against FDA. (subscription to Law360 required) In June 2008, FDA mistakenly linked a multistate Salmonella outbreak to tomatoes and warned consumers about the potential dangers associated with the consumption of raw red tomatoes in New Mexico and Texas.  Federal and state officials struggled to track the actual … Continue Reading

Tattoo Troubles

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FDA issues warning about bacterial contamination in tattoo inks. FDA has the authority to regulate the safety of cosmetics in the United States.  Tattoo inks meet the statutory definition of a “cosmetic,” which means:  “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part … Continue Reading

Doubling Up

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U.S. food recalls have nearly doubled over the past decade. Food recalls occur with relative frequency in the United States, with the reasons for such recalls ranging from labeling issues to food safety concerns, such as potential contamination with pathogens like Salmonella, Listeria, or E. coli.  FDA posts up-to-date information regarding food recalls on its website. A recent … Continue Reading

Blue Bell Blues

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FDA issues public update regarding listeriosis outbreak linked to ice cream products. FDA has many tools in its arsenal to prevent and respond to food contamination issues; these include the Agency’s inspection power and various enforcement authorities (e.g., warning letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  In … Continue Reading

(Re)call and Answer

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FDA publishes draft guidance on mandatory food recalls. Among other things, the FDA Food Safety Modernization Act (FSMA) granted the Agency the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded and that use of or exposure to the food will cause … Continue Reading
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