FDA CDC News

Federal Court Enters Consent Decree Against Florida-based Drug Importer and Distributor

Published

2 years ago

January 31, 2023

Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API), used by the company’s customers to manufacture and/or compound finished drug products, and two of the company’s executives, Chief Executive Officer and part owner, Prasad Raje, and Shailesh Vengurlekar, the company’s Senior Vice President of Quality and Regulatory Affairs.

The consent decree sets a strict timetable and requirements for the firm to ensure it obtains compliance with current good manufacturing practice (CGMP) requirements under the Federal Food, Drug, and Cosmetics Act (FD&C Act). Among other things, the consent decree requires ongoing compliance auditing and reporting to the U.S. Food and Drug Administration and also provides that the FDA may take appropriate action, including ordering the company to cease receiving, labeling, holding and/or distributing any or all drug substances, in the event the defendants further violate the FD&C Act, its implementing regulations or the consent decree.

According to the complaint filed by the U.S. Department of Justice on behalf of the FDA, LGM Pharma LLC introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements under the FD&C Act.

“Protecting patients means we must hold all parts of our drug supply chain to the highest standards of quality allowed by law, including importers and distributors of both finished drug products and active pharmaceutical ingredients,” said Jill P. Furman, J.D., acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “LGM Pharma LLC’s failure to adhere to CGMP requirements put patients at risk. This consent decree requires the firm to implement and adhere to rigorous quality standards, under close FDA supervision. We will continue to do everything in our power to ensure compliance and address violations of federal law to protect the American public and the safety of the drug products they rely on.”

The agency inspected the company’s Florida and Kentucky facilities in 2022. During these inspections, the FDA identified significant departures from CGMP requirements, including the company’s failure to perform adequate investigations of quality-related customer complaints involving out-of-specification (OOS) API that it distributed, failure to adequately qualify foreign manufacturers of API imported and distributed by the company and failures to establish adequate procedures for the distribution of drugs after an API supplier has been disqualified by the company. A previous inspection of LGM Pharma LLC’s Kentucky facility also revealed significant non-compliance with CGMP requirements, including the company’s improper re-labeling of API, lack of sufficient qualification procedures for the company’s foreign API suppliers and failure to perform adequate investigations of quality-related customer complaints involving OOS API distributed by the company.

Today’s action will require the company to undertake detailed quality-related compliance actions to ensure that the company’s processes for importing and distributing drugs conform to CGMP requirements and federal law.

The case was filed by the U.S. Department of Justice’s Consumer Protection Branch, on behalf of the FDA.

Author

Daily News Staff

View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Related Topics:Consent Decree Drug Importer FDA

Up Next

TODAY IS NATIONAL GROUNDHOG DAY

Don't Miss

National Poll: Some parents may not be making the most of well child visits

Daily News Staff

Blog

Major Ice Cream Recall: Wells Enterprises Pulls Thousands of Products Nationwide

Published

3 days ago

May 18, 2025

Rod Washington

scooping chocolate ice cream

Wells Enterprises, Inc., America’s largest privately held, family-owned ice cream manufacturer, has initiated a nationwide voluntary recall affecting more than 50,000 gallons of ice cream and frozen yogurt products due to potential plastic contamination.

Key Recall Details

Affected Products: Nearly 18,000 three-gallon containers across 22 varieties

Popular Brands Involved: Blue Bunny, Halo Top, and other Wells Enterprises products

Distribution: Products shipped to 103 distribution centers nationwide

Best-By Dates: March through October 2026

Recall Classification: FDA Class II recall

Consumer Safety Alert

The company took immediate action after discovering the possibility of foreign material (plastic) in select products. While no injuries have been reported, consumers are urged to:

Check product codes against the recall list

Stop using affected products immediately

Return items to the place of purchase for a full refund

Contact Wells Enterprises customer service with questions

Affected Product Information

The recall specifically impacts 3-gallon bulk containers of various ice cream and frozen yogurt flavors. Wells Enterprises, known for producing popular brands including Blue Bunny, Halo Top Creamery, and The Cheesecake Factory At Home ice cream products, initiated the voluntary recall on April 25, 2025.

For More Information

Consumers can visit the FDA’s official website or follow STM Daily News’ Food and Drink section for the latest updates on this recall and other food safety alerts.

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

News

Coca-Cola Recall Alert: Thousands of Cans Pulled From Shelves in Two States

Published

2 months ago

March 27, 2025

Hal Machina

selective focus photography of red coca-cola can lot on box — Photo by Craig Adderley on Pexels.com

In a significant recall notification, Coca-Cola has announced the withdrawal of over 10,000 cans of its popular beverage due to concerns over foreign object contamination. This announcement was initially made on March 6, and affected cans were sold in the states of Illinois and Wisconsin.

This week, the U.S. Food and Drug Administration (FDA) classified the risk level of this recall as Class 2. This designation indicates that consuming the affected Coca-Cola “may cause temporary or medically reversible adverse health consequences,” although the chances of serious health consequences are deemed to be remote.

Which Coca-Cola Products Were Recalled?

The recall impacts a total of 864 packs of 12 cans of Coca-Cola, amounting to 10,368 cans in total. The specific details of the recalled products are as follows:

Product Description: Coca-Cola Original Taste, 12 Fl Oz
Can UPC: 0 49000-00634 6
12-Can Pack UPC: 0 49000-02890 4
Date Code: SEP2925MDA
Time Stamp: 1100-1253

Which States Are Affected?

The recall specifically concerns Coca-Cola cans distributed in the following states:

Illinois
Wisconsin

Why Were the Coca-Cola Cans Recalled?

The FDA has reported that these Coca-Cola cans were recalled due to contamination with a foreign object, in this case, plastic. Such contaminants can inadvertently enter food and beverage products at various stages during the production process, posing a safety risk if ingested. It is important to note that the FDA report did not indicate any associated injuries related to this specific recall

If you have purchased Coca-Cola cans with the above UPC codes in Illinois or Wisconsin, it is recommended that you refrain from consuming the affected products. Instead, please return them to the store where you purchased them for a full refund or exchange. Staying informed about product recalls is crucial to consumer safety, and it is always advisable to check for the latest updates from the FDA and Coca-Cola regarding product safety issues. For any additional questions, feel free to reach out to Coca-Cola directly or visit the FDA’s website. Stay safe!

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

FDA CDC News

Alert: Kroger Issues Food Recalls Affecting Multiple States

Published

3 months ago

February 7, 2025

Hal Machina

Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

King Harvest Lemon Hummus
King Harvest Classic Hummus
King Harvest Roasted Garlic Hummus
King Harvest Toasted Onion Hummus
King Harvest Chipotle Hummus
King Harvest Spinach Hummus
King Harvest Black Olive Hummus
King Harvest Sesame Hummus
King Harvest Jalapeño Hummus
King Harvest Balsamic Hummus
King Harvest Sun Dried Tomato Hummus
King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

DJs Boudain Hot Jalapeño Boudain, 12 oz
DJs Boudain Boudain Sausage, 24 oz
DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

https://stmdailynews.com/

Author

Hal Machina

Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries! View all posts journalist