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Showing 2201–2220 of 14370 results

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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.

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

Fyarro (Aadi Bioscience) – Stability Specification Failure (2022)

Failed Stability Specifications

FDAOct 13, 2022AL, KY, PA +1 more• Aadi Bioscience

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.

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.

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.

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

CGMP Deviations:

Class IIModerate

FDAOct 13, 2022Nationwide• Akorn, Inc.

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

FDAOct 11, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Walgreens Sinus Medicine (LNK International) – Mislabeled Ingredients (2022)

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

FDAOct 11, 2022Nationwide• LNK International, Inc.

Papaverine Phentolamine Injection (Vital Care) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Octreotide Acetate Injection (Viatris) – glass particle risk (2022)

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

FDAOct 7, 2022Nationwide• Viatris Inc

Acetylcysteine Ophthalmic Solution (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Papaverine/Phentolamine/Prostaglandin (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

Talc Sterile Powder (Vital Care) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Class IIModerate

FDAOct 7, 2022AL, LA, MS +1 more• Pharmacy Plus, Inc. dba Vital Care Compounder

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