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Ketotifen Fumarate Eye Drops (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAMay 1, 2023IN, PA• RemedyRepack Inc.

truCONTROL 60 Count (TruVision Health LLC) – Unsafe Ingredients (2023)

The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.

Class IIModerate

FDAApr 27, 2023AL, AK, AZ +47 more• TruVision Health LLC

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Ketotifen Fumarate Eye Drops (RemedyRepack) – Quality Program Issue (2023)

truCONTROL 60 Count (TruVision Health LLC) – Unsafe Ingredients (2023)

TruBoost Drink - Citrine Spark (TruVision Health LLC) – Unsafe Ingredients (2023)

TruBoost Experience Kit (TruVision) – unsafe ingredients (2023)

Truvy 7-Day Kit (TruVision) – unsafe ingredients (2023)

truControl W/Dynamine 60 ct (TruVision Health LLC) – Unsafe Ingredients (2023)

Truvy Boost 30-Day Kit (TruVision Health LLC) – Unsafe Ingredients (2023)

Truvy 30-Day Kit (TruVision) – unsafe ingredients (2023)

TruBoost Drink - Ruby Rev (TruVision Health LLC) – Unsafe Ingredients (2023)

reFORM (TruVision Health LLC) – Unsafe Dietary Ingredients (2023)

TruWeight and Energy Trifold (TruVision) – unsafe ingredients (2023)

TruControl 7 Day Trifold (TruVision Health LLC) – Unsafe Ingredients (2023)

TruWeight and Energy Gen 2+ (TruVision) – unsafe ingredients (2023)

Lorazepam Injection (Akorn) – Stability Study Halt (2023)

Ferrous Sulfate Drops (Akorn) – Stability Study Halt (2023)

Diuril Injection (Akorn) – Stability Studies Discontinued (2023)

Megestrol Acetate Suspension (Akorn) – Stability Study Halt (2023)

DetomiSed (Akorn) – Business Closure Stability Issue (2023)

XOPENEX Inhalation Solution (Akorn) – Stability Study Halt (2023)

Naloxone Injection (Akorn) – Stability Study Halt (2023)