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Akorn, Inc.

Akorn, Inc. Recalls

All product recalls associated with Akorn, Inc..

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Recall Summary

Total Recalls

118

Past Year

0

Class I (Serious)

0

Most Recent

Apr 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 81–100 of 118 recalls

Cromolyn Sodium Ophthalmic Solution (Akorn) – Stability Study Halt (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Acyclovir Oral Suspension (Akorn) – Stability Studies Discontinued (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Lidocaine HCl Jelly (Akorn) – Stability Studies Discontinued (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Lorazepam Oral Concentrate (Akorn) – Stability Studies Discontinued (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Valproic Acid Oral Solution (Akorn) – Stability Studies Discontinued (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Acetaminophen & Codeine Oral Solution (Akorn) – Stability Studies Discontinued (2023)

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

Class IIModerate

FDAApr 26, 2023Nationwide• Akorn, Inc.

Atropine Sulfate Eye Solution (Akorn) – Failed Stability (2023)

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

FDAJan 30, 2023Nationwide• Akorn, Inc.

Cromolyn Sodium Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Erythromycin Ophthalmic Ointment (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Olopatadine HCl Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

PAREMYD Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Ofloxacin Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Ketorolac Tromethamine Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Betaxolol Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Olopatadine HCl Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Olopatadine HCl Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Lidocaine Hydrochloride Jelly (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Proparacaine Hydrochloride Ophthalmic Solution (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Tobramycin Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Tobramycin Ophthalmic Solution (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

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