Bellapierre Cosmetics, a cosmetics company based in the Dominican Republic, is recalling some of its products due to “possible chemical toxicity.”
The company has confirmed it has received “an alert from the Food and Drug Administration (FDA) for suspected chemical toxicity due to the formulation used in some of the products,” the company said in a statement on its website.
“We immediately notified the FDA of the incident and have since taken the necessary precautions.”
According to the company, the recalled products are “in the process of being recalled.”
The announcement comes after a series of deaths linked to the drug, including two deaths in April and another two in May.
The FDA said the products were tested at the time of the recall and found to contain the active ingredient, a form of the drug called diclofenac.
“Diclonefenac is a known human carcinogen that is known to cause lung and liver damage,” the agency said in the statement.
“It has been used in a variety of medical procedures, including surgery, radiation, skin and blood therapies and skin and mucosal care products, as well as dental implants and facial prostheses.”
The FDA added that it was “monitoring the situation in this recall.”
“The products are being distributed through authorized retail outlets, including Bellapreme, Bellapreem, Bellapoem, and Bellaprepreem.”
In a statement released Tuesday, the company thanked its customers and said it was working with the FDA to address the problem.
“Bellapreme and Bellapoepreem have been tested for diclosporin, diclonadol and the active ingredients of diclisofenadine and diclatasfenactone in the United States and Mexico.
The products are safe to use,” the statement said.
“As part of this investigation, the FDA conducted a chemical analysis of a batch of the recalled product, which was sent to our manufacturing facility for testing.”
The recall affects products that are currently being sold in the U.S. and in Canada, according to the statement, and may affect other countries as well.
The statement also said that Bellapère, which has about 15 employees, will be providing refunds to customers.
“If you have a Bellaprene product that is not being sold on the Bellaprea website, we will refund you $25 for any remaining product purchased,” the message said.
In a recent interview with Bloomberg, Bellapereem co-founder Luis Aragones said the company was “very shocked and saddened” by the news.
“The company is very aware of the possibility of exposure,” he said.