CelestaPro
FDA issued a warning letter to CelestaPro (www.celestapro.com) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Nabota 200 Unit,' to U.S. consumers without an FDA-approved new drug application under section 505 of the FD&C Act. The product was identified as a drug intended for human use based on the claim 'Hyperhidrosis' listed under 'Application area' on the website. FDA found the product misbranded because its labeling lacks adequate directions for use as required for prescription drugs. CelestaPro was directed to cease sales of unapproved and misbranded drugs and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (1)
Hyperhidrosis
Required actions (3)
FDA requests that www.celestapro.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
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