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FDA Warns 5 Manufacturers Selling Homeopathic Products

The U.S. Food and Drug Administration has issued warning letters to five companies that manufacture products labeled as homeopathic for violating manufacturing regulations.

The agency has sent letters to Kadesh, Inc., U.S. Continental, Inc., Fill It Pack It, Inc. and Bershtel Enterprises LLC, which jointly make and package Puriton Eye Relief Drops.

The FDA said it tested multiple samples and found these eye drops were non-sterile, which could lead to an eye infection. The results also showed high pH level in the product, which could lead to eye injury such as glaucoma, corneal scarring and loss of vision. Kadesh issued a voluntary recall in November 2018 due to non-sterile production conditions at the manufacturing facility.

"It's our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately," said FDA Acting Commissioner Ned Sharpless, M.D. "When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk."

FDA sent another warning letter to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations.

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