An Englewood medical spa is recalling more than 1,500 injections of weight-loss drugs and vitamin cocktails after an inspection found its employees handled the drugs in a way that could introduce contamination.
Thrive Health Solutions, which offers hormone therapy and weight-loss drugs, among other injectable medications, voluntarily recalled the following products:
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- 854 syringes of tirzepatide, which sells under the brand names Zepbound and Mounjaro
- 458 syringes of tirzepatide and vitamin B12
- 196 syringes of semaglutide, which sells under the brand names Ozempic and Wegovy
- 102 syringes of LX Bioboost Plus, which contains vitamins and other ingredients, including a small amount of the topical anesthetic lidocaine
- 64 syringes of LL Boost, which contains vitamin B12, amino acids and other ingredients
- 60 syringes of CJC-1295, which stimulates the release of growth hormone
- 32 syringes of nicotinamide adenine dinucleotide, a substance the body uses to process energy
- 28 syringes of semaglutide and vitamin B12
- Five syringes of methylcobalamin, a form of vitamin B12
An inspection by the U.S. Food and Drug Administration in late March and early April found employees mixed doses of drugs in a room that doubled as an office and had surfaces that would be difficult to keep sterile. At least one person didn’t wear full personal protective equipment to prevent contamination of the drugs.
The FDA hasn’t released any reports of infections or other harm to patients.
A person answering the phone at Thrive declined to comment and told a reporter “to get your facts straight, first and foremost,” but hung up when asked what was wrong with the premise of an article about the facility’s recalls.
Thrive also faces a lawsuit from drugmaker Eli Lilly for allegedly making false claims about FDA approval when selling a compounded version of tirzepatide, a diabetes and weight-loss drug. Eli Lilly sells tirzepatide under the brand names Zepbound and Mounjaro.
Compounding pharmacies generally create custom medications for patients’ specific needs, but can also sell versions of an existing drug during an FDA-declared shortage. The FDA doesn’t regulate compounding pharmacies’ products or guarantee they are safe and effective.
A post on Thrive’s website, dated April 5, said the company could no longer provide compounded tirzepatide or semaglutide, because the FDA had found the original drugs were no longer in a shortage. The company said that it could continue to sell compounded versions by mixing them with other, unspecified ingredients to suit customers’ needs.
Adding easily available ingredients, such as vitamin B12, wouldn’t make compounded versions of weight-loss drugs legal now that the shortage is over, according to GoodRx. A patient must have a medical need that they can’t meet with existing FDA-approved drugs for a compounding pharmacy to be justified in a custom formulation.
The formulations Thrive was selling were legal at the time of the inspection.
The FDA reported 1,000 adverse events related to compounded tirzepatide and semaglutide, but didn’t specify how many were serious. The agency doesn’t deeply investigate all adverse events, so an unknown number could be coincidences or caused by another factor, such as the patient taking a larger-than-prescribed dose.
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