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

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

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

Undeclared Allergen

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

FDA

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

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

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

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

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

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

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

Acetic Acid Otic Solution (Akorn) – Stability Studies Discontinued (2023)

Oxcarbazepine Suspension (Akorn) – CGMP Deviation (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)

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

Olopatadine HCl Ophthalmic Solution (Akorn) – Stability Study Halt (2023)

Proparacaine HCl Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)

Lidocaine Ointment (Akorn) – CGMP Deviation (2023)

Clobetasol Propionate Ointment (Akorn) – Stability Study Halt (2023)

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

Olopatadine HCl Ophthalmic Solution (Akorn) – Stability Studies Discontinued (2023)