Recall D-0393-2024
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.
Recall D-0393-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0393-2024 |
Event ID | 93946 |
Distribution | Nationwide in the U.S. |
Quantity | 3,573 bottles |
Recall Reason | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. |
Drug Classification | Class I |
Drug Code Info | 20240327 |
Recall Initiation Date | 20240205 |
Report Date | 20240327 |
Classification Date | 20240321 |
Address | 827 6th Ave New York, NY 10001-6305 United States |
Recalling Firm | Super Chill Products |
Initial Notification | Letter |
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