ALVA-AMCO Pharmacal Companies, LLC
FDA issued a warning letter to ALVA-AMCO Pharmacal Companies, LLC regarding their 'Nauzene Kids' homeopathic product, finding it to be an unapproved new drug under section 505(a) of the FD&C Act. The product's label and website made drug claims (nausea and upset stomach relief) without an FDA-approved application, and the product is not generally recognized as safe and effective for its intended uses. Additional concern was raised because the product is directed at young children and was manufactured by a facility with known CGMP violations. FDA demanded written corrective action within fifteen working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (6)
Trusted Relief for Upset Stomachs Caused by . . . Diet . . . Stomach Bug . . . Motion Sickness . . . Nervous Stomach
For Nausea & Upset Tummies
Promptly relieves nausea and upset tummies – even from the 'stomach flu' and 'car sickness'
The Easy Fix for Upset Stomachs & Nausea
Relief of Nauseas From: 'Car Sickness' 'Stomach Flu' 'Upset Tummies'
For the relief of upset stomach and nausea, including that due to 'stomach flu,' 'car sickness' or overindulgences in food or drink.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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