FDA Recalls Unapproved hCG Body Shaper Product for Contamination
The FDA is recalling hCG Body Shaper because it was marketed without approval and contains human chorionic gonadotropin, making it an unapproved drug.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant health risks or regulatory violations involving unapproved drugs.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling hCG Body Shaper, a product distributed by HCG Body Shaper in St. Peters, Missouri. The product is described as containing Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, and stabilizers/excipients. The recall involves approximately 1,305 to 1,400 bottles that were distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product is tainted with human chorionic gonadotropin, which renders it an unapproved drug. The bottles do not have code information printed on them.
Consumers who have purchased this product should stop using it and contact the recalling firm, Gary Wood, for further instructions. The product is labeled 'Not For Medical Use' and 'Must Be Refrigerated,' but its presence of unapproved active ingredients poses a regulatory and safety concern.
The recalled product
- Product
- hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
- Manufacturer
- Gary Wood
- Category
- Drug — Unapproved Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No code information printed on bottle
Distribution
Distributed nationwide across the United States.
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