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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

Class I (Serious)

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 101–118 of 118 recalls

Erythromycin Ophthalmic Ointment (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

AK-POLY-BAC Ophthalmic Ointment (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Artificial Tears Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Timolol Maleate Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Neomycin Polymyxin Bacitracin Ointment (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Proparacaine Hydrochloride Dropper Solution (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.

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Sodium Chloride Ophthalmic Ointment (Akorn) – Manufacturing Quality Issues (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

GONAK Hypromellose Ophthalmic Solution (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Levofloxacin 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.

Artificial Tears Ointment (Akorn) – CGMP Deviations (2022)

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Rifampin Capsules (Akorn) – Impurity Specification Failure (2022)

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Class IIModerate

FDASep 21, 2022Nationwide• Akorn, Inc.

Rifampin Capsules 150mg (Akorn) – impurity specification (2022)

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Class IIModerate

FDASep 21, 2022Nationwide• Akorn, Inc.

Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.

Class IIILow

FDAAug 8, 2022Nationwide• Akorn, Inc

PrednisoLONE Oral Solution (Akorn) – Incomplete Seals (2022)

Defective Container: Product has incomplete induction seals.

Class IIModerate

FDAAug 1, 2022Nationwide• Akorn, Inc

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