Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine
Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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II, which corresponds to a Severe severity score under the rubric, particularly given the presence of an undeclared, withdrawn drug (sibutramine) in a consumer product.
Plain-English summary
Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement 30-count capsules. The product is identified by Lot 1220062085 and an expiration date of 03/2020. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sibutramine.
The affected product was distributed nationwide within the USA. Sibutramine is a drug that was withdrawn from the market due to safety concerns, and its presence in a dietary supplement without proper regulatory approval poses a health risk to consumers.
Consumers who have purchased this product should stop using it immediately. They should contact Zero Xtreme USA for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
- Manufacturer
- Zero Xtreme USA
- Category
- Drug — Dietary Supplement
- Affected units
- 16
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)
- Lot: 1220062085 Exp. 03/2020
Distribution
Distributed nationwide across the United States.
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