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en Español [7/3/2023]  Since April 20, 2022, FDA learned that more than 30 additional consumers have experienced a serious health effect after using unapproved over-the-counter products with “Artri” or “Ortiga” in the product name. Reported harmful effects include sudden weight gain, serious gastrointestinal damage including bleeding and ulceration, increased blood glucose (sugar) levels, adrenal dysfunction, liver toxicity, and other serious conditions. Some of these problems can be life threatening or fatal. FDA continues to warn consumers to avoid use of these products that contain potentially harmful hidden ingredients. In addition, the agency issued a warning letter and an import alert for certain products. [10/28/2022]  In support of public safety, and because some of these products may still be av...

Update [2/22/2023] FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall. Update [2/21/2023] In addition to Artificial Tears products, FDA is also now warning consumers and Health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination . This is an over-the-counter product, manufactured by Global Pharma Health care Private Limited, intended to be sterile. En Español [2/2/2023] FDA is warning consumers and health care practitioners not to purchase and to immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindne...

[5/1/2023] FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These product s are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap product s. These product s may have been purchase d online through the Nose Slap website. On April 24, 2023, FDA issued a warning letter to Nose Slap LLC for marketing these unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. These product s have not been demonstrated to be safe or eff...