FDA CDC News

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status.

Published

2 years ago

November 15, 2022

Daily News Staff

Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products

Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products

Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, M.D. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The Federal Register notice includes a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone.

To make its final determination, the FDA needs additional data, such as product-specific data on the nonprescription user interface design, including packaging and labeling. These data would usually be submitted to the agency in an application for a proposed nonprescription naloxone product.

By issuing this notice, the FDA is making application holders of certain prescription naloxone drug products aware of the preliminary assessment and the possibility that the agency may make a conclusive determination, through approval of a nonprescription naloxone drug product, that such products are safe and effective for use without a prescription.

The notice does not cover all naloxone products, as more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations (including vials, ampules or syringes without integrated needles) before a preliminary assessment with respect to those products can be reached. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.

Over the last several years, the FDA has taken a number of steps to improve access to naloxone products. In September, the agency issued an immediately in effect guidance to clarify that certain Drug Supply Chain Security Act requirements do not apply to distribution of naloxone to harm reduction programs during the Opioid Public Health Emergency. Additional efforts include development of a model Drug Facts Label, which is required for OTC drug products, with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to their prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months.

The FDA continues to make progress implementing the new FDA Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S. through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

Related Information

Source: FDA

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Lifestyle

Important Recall Alert: Expanded Produce Recall Due to Listeria Concerns

Published

4 days ago

July 23, 2024

Charles Elliot, Daily News Staff

In a significant public health alert, the Ohio Department of Agriculture (ODA) has announced an expanded recall of fresh produce supplied by Wiers Farm Inc., based in Huron County. This comes amidst growing concerns about potential listeria contamination, prompting vigilance among consumers shopping at select retailers, including Walmart, Aldi, and Kroger stores across Ohio and several other states.

people at supermarket. recall — Photo by Sebastián Mera Jaramillo on Pexels.com

What You Need to Know

On July 22, 2024, Wiers Farm Inc. expanded its voluntary recall to include additional produce items that were packed between July 5 and July 12. While there have been no reported illnesses or consumer complaints to date, the ODA is taking proactive measures to ensure public safety.

Affected Products

The recall includes a variety of retail packaged items and bulk produce sold at various grocery chains. Here’s a comprehensive list of the impacted products:

Retail Packaged Items

Sold at select Walmart stores in multiple states:

Wiers Farm Bagged Poblano – UPC 073064202581 – 16 oz bag
Wiers Farm Bagged Cubanelle – UPC 073064201836 – 16 oz bag
Wiers Farm Bagged Green Beans – UPC 073064200846 – variable weight bag
Wiers Farm Bagged Salad Cucumber – UPC 073064459619 – 2 lb. bag
Wiers Farm Bagged Serrano – UPC 073064201829 – 4 oz bag
Wiers Farm Organic Bell Pepper – UPC 073064201416 – 2 count tray
Wiers Farm Organic Cucumber – UPC 073064201423 – 2 count tray
Wiers Farm Organic Yellow Squash – UPC 073064201447 – 2 count tray
Wiers Farm Organic Zucchini Squash – UPC 073064201430 – 2 count tray

Sold at Aldi stores in Ohio and nearby states:

Freshire Farms Bagged Green Beans – 16 oz bag
Freshire Farms Bagged Jalapenos – 8 oz bag

Bulk Retail Items (sold individually or by the pound)

Anaheim peppers
Cilantro (sold in bunches)
Cubanelle peppers
Whole cucumbers
Green beans
Green Bell Pepper
Habanero peppers
Hungarian Wax peppers
Jalapeno peppers
Mustard Greens (sold in bunches)
Poblano peppers
Serrano peppers
Tomatillos

In Ohio, these bulk items were distributed to Walmart, Kroger, Save-a-Lot, and local food banks in Cleveland and Youngstown.

What Should Consumers Do?

The ODA is urging consumers who may have purchased any of the listed products to discard them immediately. It’s crucial to stay informed, as listeria monocytogenes can lead to serious health issues, particularly in vulnerable populations such as pregnant women, the elderly, and those with weakened immune systems. Symptoms of listeriosis can include fever, muscle aches, and gastrointestinal distress—anyone experiencing these symptoms after consuming the recalled products should seek medical attention promptly.

Commitment to Safety

Wiers Farm Inc. has expressed its dedication to resolving this situation and ensuring the safety of its products. The ODA is actively investigating the matter, a response initiated after potential contamination was flagged during routine testing by the Michigan Department of Agriculture and Rural Development.

Stay Informed

For further inquiries or concerns, consumers can reach out to Wiers Farm at 419-933-2161. It’s essential to stay updated on recalls and food safety alerts to protect your health and the health of your loved ones.

As we navigate through these recalls, let’s remain vigilant and prioritize food safety to ensure a healthy dining experience for everyone. Remember, when in doubt, it’s better to be safe than sorry—check your pantry and fridge today!

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Consumer Corner

Important Recall Notice: Wiers Farm, Inc. Announces Voluntary Recall of Cucumbers Due to Listeria Concerns

Wiers Farm recalls cucumbers due to Listeria risk. Discard affected products immediately.

Published

1 week ago

July 19, 2024

Hal Machina, Daily News Staff

In a decisive move to ensure consumer safety, Wiers Farm, Inc., a respected distributor based in Willard, OH, has announced a voluntary recall of select cucumber products over concerns of potential contamination with Listeria monocytogenes. This recall specifically targets a limited number of whole and bagged salad cucumbers, sourced from out of state and distributed under the Wiers Farm brand.

Recall Details

Date of Announcement: July 12, 2024
FDA Publish Date: July 16, 2024
Product Types: Whole cucumbers and 2 lb bagged salad cucumbers
Pack Dates: June 5, 2024 (whole cucumbers), June 5 and 6, 2024 (salad cucumbers)
Distribution: Select Walmart stores in Michigan, Indiana, and Ohio

Reason for Recall

The potential for contamination was identified through routine sampling by the Michigan Department of Agriculture and Rural Development (MDARD). While no illnesses or customer complaints have been reported to date, Wiers Farm is proceeding with the utmost caution to safeguard its customers.

About Listeria

Listeria monocytogenes is a bacteria capable of causing the serious infection known as listeriosis. It primarily affects pregnant women, newborns, the elderly, and adults with weakened immune systems. Symptoms include fever, muscle aches, nausea, and diarrhea. If you have consumed any of the recalled products and are experiencing these symptoms, it is advised to seek medical attention promptly. More information about Listeria can be found on the Centers for Disease Control and Prevention (CDC) website.

Product Identification

Whole Cucumbers: Approximately 1.5-2.5 inches in diameter and 6-9 inches in length
Bagged Salad Cucumers: Packaged in a clear bag with a blue base, marked with the specified pack dates

Consumer Action

Consumers in possession of the affected cucumbers are urged not to consume them. Even though the products are past their shelf life and likely out of distribution, if you still have them, please safely dispose of them immediately. Questions or concerns can be addressed by contacting Wiers Farm customer care at (419) 933-2161 or via email at customercare@wiersfarm.com.

Company Statement

Wiers Farm has expressed its commitment to the highest standards of food safety and health. “We have taken immediate steps to address this isolated incident and are collaborating closely with the Ohio Department other traceability data to ensure that the product in question is swiftly and effectively removed from all channels,” stated a company spokesperson.

Summary

This recall serves as a reminder of the importance of stringent safety measures in the food distribution process. Wiers Farm’s proactive steps in recalling potentially affected products underscore their dedication to consumer safety and health standards. Consumers are advised to follow recall instructions and dispose of any questionable products to ensure health and safety.

FDA notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria

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FDA CDC News

Immediate Recall Alert: Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad

Reser’s recalls Hill Country Fare Mustard Potato Salad due to potential plastic contamination. Return for a refund if purchased.

Published

1 week ago

July 18, 2024

Charles Elliot, Daily News Staff

In a decisive action prioritizing consumer safety, Reser’s Fine Foods has issued a voluntary recall for one of its popular products, the Hill Country Fare Mustard Potato Salad, available in 48 oz (3LB) containers. This recall specifically targets products with a Use By Date of JUL/26/24. The reason behind this precautionary step is the discovery of potential contamination from pieces of hard plastic, which could present a health risk to consumers.

Key Details of the Mustard Potato Salad Recall:

Company Announcement Date: July 02, 2024
FDA Publish Date: July 09, 2024
Product Type: Food & Beverages
Reason for Recall: Possibility of Hard Plastic Foreign Material
Company Name: Reser’s Fine Foods
Brand Name: Hill Country Fare
Product Description: Mustard Potato Salad

This product was exclusively distributed through H-E-B and Joe V’s Smart Shop stores located within Texas and was produced at a regional facility operated by Reser’s Fine Foods. It is important to note that, fortunately, no injuries or adverse effects have been reported as of now.

Consumer Safety Measures

To prevent any potential hazards, all affected product batches have been removed from retail shelves. Reser’s urges consumers who have purchased this specific product to avoid consuming it. Instead, they should return it to the store where it was purchased for a full refund or safely dispose of it.

Contact Information for Consumer Inquiries:

For those with further questions or in need of additional information regarding this recall, Reser’s Fine Foods has made provisions for customer communication. You can reach them at:

Phone: 888-223-2127
Operational Hours: Monday to Friday, from 8:00 AM to 5:00 PM Pacific Time.

Why This Recall Matters

Recalls are a vital part of ensuring safety in the food supply chain. Reser’s Fine Foods has taken this proactive step out of an abundance of caution to protect its consumers from any possible harm. Such actions reflect a commitment to high standards of food safety and consumer protection.

Taking Action

If you have purchased the recalled Hill Country Fare Mustard Potato Salad, check the packaging for the specified Use By Date, and follow the outlined safety guidelines. It’s also wise to keep abreast of updates from Reser’s Fine Foods and the FDA.

This voluntary recall showcases the importance of rigorous quality checks and responsiveness in addressing any potential risk swiftly. For continued safety, keep informed about the latest food recalls and guidelines issued by health and food safety organizations.

Closing Thoughts

Reser’s Fine Foods remains dedicated to upholding the highest levels of safety and quality and is actively working on measures to prevent future issues. Consumers can rest assured that swift actions like these reflect a commitment to their well-being.

For continuous updates, stay tuned to the FDA’s announcements or sign up for direct alerts from food safety authorities to ensure you and your lovedators are always protected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624

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