Dietary Supplement Marketed as Unapproved Drug Without FDA Approval
Stop Clopez Corp's Schwinnng Herbal Dietary Supplement Capsules were distributed worldwide via Amazon without FDA approval as a new drug. Consumers should discontinue use immediately.
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: FDA Class I recall classification requires a minimum severity score of 4. This recall involves marketing a product as a pharmaceutical drug without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which is a regulatory violation under FDA law.
Plain-English summary
Schwinnng Herbal Dietary Supplement Capsules, manufactured by Stop Clopez Corp and distributed by VSD Productions Inc. in Las Vegas, Nevada, have been recalled due to being marketed as a drug without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) from the FDA.
The product was marketed as a pharmaceutical drug product but did not obtain the required FDA approval. This constitutes an unapproved drug product under Federal Food, Drug, and Cosmetic Act regulations. The affected product consists of 5 boxes of Schwinnng Herbal Dietary Supplement Capsules (Lot 2108, expiration 10/31/2024) that were distributed worldwide through amazon.com.
Consumers who purchased this product should stop using it immediately and not consume any remaining capsules. For return, refund, or additional information regarding this recall, consumers should contact the FDA at www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
- Manufacturer
- Stop Clopez Corp
- Category
- Drug — Herbal Dietary Supplement
- Hazard
- 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 (2)
- Lot 2108
- EXP 10/31/2024
Distribution
Distribution scope not specified by the agency.
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