FDA Warns About Generic Weight Loss Drugs Distributed by SoCal Company

ONTARIO, CA – Popular weight loss treatments – such as Lilly’s Zepbound and Novo Nordisk’s Wegovy – have boosted demand from consumers looking to shed unwanted pounds. As a result, many compounding drug companies have developed a revenue stream from distributing some type of product.

But the US Food and Drug Administration on Friday also warned that these combined weight-loss drugs could harm patients.

The latest red flag stems from contamination concerns at a Southern California compound. According to the FDA, the injectable semaglutide and tirzepatide combined and distributed by Ontario, Calif.-based Fullerton Wellness LLC may not be sterile.

“Based on conditions observed by the FDA and information provided by California regulatory authorities, the FDA is concerned about the ineffectiveness of the drugs distributed by Fullerton Wellness,” according to the Nov. 1 FDA. “Fullerton Wellness used sterile ingredients to make these injectable drugs and did not take steps to sanitize them, which could pose health risks.

The FDA warned: “Administration of an impure drug that is intended to be sterile can cause potentially life-threatening side effects including infection and sepsis.”

Injectable tirzepatide is sold under Lilly’s Mounjaro and Zepbound brands, and injectable semaglutide is sold under Novo Nordisk’s Ozempic and Wegovy. GLP-1 drugs (glucagon-like peptide-1 receptor agonists) have been approved by the FDA and no safety warnings were issued for them as part of the Nov. 1.

Instead, it is the combined types of drugs that provide the warning. Compounding drugs is the process of mixing, combining or changing ingredients. Compounding can be an important safety net when FDA-approved drugs are not available, but compounding drugs are not FDA-approved and instead regulated by the government.

Concerns about Fullerton Wellness began on August 14, after the FDA received a complaint from a patient who noticed a “black substance” in a vial of compounded semaglutide distributed by the company. Then, on September 23, the FDA received information from California regulatory authorities about “deficiencies” at Fullerton Wellness during a state inspection, the FDA reported.

On October 17, the FDA contacted federal authorities at the Ontario facility and “observed conditions that could cause the drugs produced by the company to be contaminated,” the FDA advised.

Patch called Fullerton Wellness on Monday, but the phone number was disconnected. According to the FDA, Fullerton Wellness voluntarily stopped.

The FDA is urging health professionals to review their medical devices and stop dispensing any Fullerton Wellness products.

“Patients who have received combination drugs distributed by Fullerton Wellness should stop using them and contact their health care professional,” according to the FDA.

The recent advice on combined GLP-1 drugs was not the first. In July, the FDA issued a warning to patients and health care professionals who are using unauthorized types of drugs for weight loss.

“This can be dangerous for patients, as unapproved versions are not evaluated by the FDA for safety, effectiveness and quality before they are sold,” according to the federal agency.

The FDA said in July that it is working with its federal regulatory partners and “will continue to communicate with compounders regarding these concerns.”

Patients and healthcare professionals should report any adverse drug reactions to the FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the appropriate form, then fax it to 1-800-FDA-0178.