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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0393-2024
Event ID93946
DistributionNationwide in the U.S.
Quantity3,573 bottles
Recall ReasonMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Drug ClassificationClass I
Drug Code Info20240327
Recall Initiation Date20240205
Report Date20240327
Classification Date20240321
Address827 6th Ave
New York, NY 10001-6305
United States
Recalling FirmSuper Chill Products
Initial Notification Letter
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