Cheap Medicine Shop/www.cheapmedicineshop.com
FDA issued a warning letter to Cheap Medicine Shop (www.cheapmedicineshop.com), an India-based online pharmacy, for selling unapproved and misbranded injectable semaglutide products — specifically 'Semanext Injection' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The product's labeling also failed to bear adequate directions for use, constituting misbranding under section 502(f)(1). FDA warned that failure to correct these violations may result in seizure, injunction, or refusal of admission of products at the U.S. border, and required a written corrective response within 15 business days.
Flagged claims (1)
Semanext Injection is a weekly injectable medicine used for controlling blood sugar in adults. It also supports weight loss and obesity management in individuals with weight-related health conditions.
Required actions (3)
FDA requests that www.cheapmedicineshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Send your written response to [email protected] within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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