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Lifted Made-Lemon Tablet (Eden's Elixirs) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Mint Flavored Tablets (Eskay Brands) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Mint Flavored Tablets (Lifted Made) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Fluoxetine Tablets (Torrent Pharma) - CGMP Nitrosamine Deviation (2025)

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Class II

FDAMay 27, 2025Nationwide• Torrent Pharma Inc.

Irbesartan Tablets 300mg (AvKARE) – Dissolution Issue (2025)

Out of Specification for Dissolution

Class II

FDAJan 21, 2025Nationwide• AvKARE