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Showing 1461–1480 of 2326 results

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Glycopyrrolate Tablets (Aurolife) – Impurity Specifications (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 16, 2022Nationwide• Aurolife Pharma, LLC

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDANov 22, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Daytrana (Noven) – Defective Adhesive System (2022)

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Class IIModerate

FDANov 16, 2022Nationwide• Noven Pharmaceuticals Inc

Sodium Chloride Injection (ICU Medical) – Sterility Compromise (2022)

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Class IIModerate

FDANov 9, 2022Nationwide• ICU Medical Inc

Hand Sanitizer (Adam's Polishes) – Manufacturing Deviation (2022)

CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDANov 5, 2022Nationwide• Adam's Polishes LLC

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.

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

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.

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