Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

Class IIILow

FDAOct 18, 2022Nationwide• Genentech Inc

Buprenorphine and Naloxone Sublingual Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence of Foreign Substance

Class IIModerate

FDAOct 18, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Cromolyn Sodium 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.

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.

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.

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.

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