FDA Recalls Unapproved Tianeptine Elixir Drug Product Nationwide
Neptune's Fix Tianeptine Elixir, distributed nationwide by Super Chill Products, is recalled because it contains tianeptine, a substance not approved by the FDA for any medical use in the United States. Consumers should not use this product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls must have a severity of at least 4. No reported illnesses or deaths are mentioned in the source, so the score is 4 rather than 5.
Plain-English summary
Neptune's Fix, Tianeptine Elixir is being recalled due to FDA Class I concerns. The product, a 0.338 fl.oz. (10 mL) bottle distributed nationwide by Super Chill Products of New York, contains tianeptine, a substance that has not been approved by the FDA for any medical use in the United States.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which are required for all drugs sold in the United States. As a result, the safety and efficacy of this product have not been evaluated by the FDA.
Approximately 3,573 bottles of this product were distributed nationwide. Consumers who have purchased this product should stop using it immediately and dispose of it safely.
For questions about this recall, contact Super Chill Products or the FDA.
The recalled product
- Product
- Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
- Manufacturer
- Super Chill Products
- Category
- Drug
- Hazard
- Affected units
- 3,573
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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