Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th
Summary
The FDA issued a Class I for Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Dist by Super Chill Products. Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States..
Details
Source
Drug Recall
External ID
D-0393-2024
Action Date
2024-03-27
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: All lots within expiry
Quantity Affected: 3,573 bottles
Reason for Recall
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-05
Company
New York, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Super Chill Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Super Chill Products have FDA actions?
This is the only FDA action we have on record for Super Chill Products in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0393-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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