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NUX Male Enhancement Capsule (Gadget Island) – Undeclared Ingredients (2023)

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Class IHigh

FDAApr 26, 2023Nationwide• Gadget Island, Inc

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

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIModerate

FDAApr 26, 2023Nationwide

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NUX Male Enhancement Capsule (Gadget Island) – Undeclared Ingredients (2023)

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

Tropicamide Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)

Ketorolac Tromethamine Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)

Cetrorelix Acetate Injection (Akorn) – Stability Studies Discontinued (2023)

Promethazine HCl Oral Solution (Akorn) – Stability Studies Discontinued (2023)

Gonak Hypromellose Eye Solution (Akorn) – CGMP Deviation (2023)

Pilocarpine Hydrochloride Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)

Midazolam Injection (Akorn) – CGMP Deviation (2023)

Trihexyphenidyl Hydrochloride Oral Solution (Akorn) – Stability Studies Discontinued (2023)

Neomycin & Polymyxin B Ophthalmic Ointment (Akorn) – Stability Studies Discontinued (2023)

Sodium DIURIL (Akorn) – Stability Studies Discontinued (2023)

Granisetron Injection (Akorn) – CGMP Deviation (2023)

Ropivacaine Hydrochloride Injection (Akorn) – Stability Studies Discontinued (2023)

Lactulose Solution (Akorn) – Stability Studies Discontinued (2023)

Calcipotriene Scalp Solution (Akorn) – CGMP Deviation (2023)

Olopatadine Nasal Spray (Akorn) – CGMP Deviation (2023)

Oxcarbazepine Suspension (Akorn) – CGMP Deviation (2023)

Guaiatussin AC Sugar-Free (Akorn) – Business Closure Stability Issue (2023)

Azelastine Hydrochloride Nasal Spray 0.15% (Akorn) – Business Closure Stability Issue (2023)