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Showing 1481–1500 of 2326 results

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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.

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.

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.

Olopatadine HCL 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.

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.

Mrs. Freshley's Apple Pie (Flowers) – Undeclared Soy (2022)

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Class IIModerate

FDAOct 7, 2022AL, AZ, AR +47 more• Flowers Foods (Corporate Offices)

Tastykake Caramel Apple Pie (Flowers) – Undeclared Soy (2022)

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Class IIModerate

FDAOct 7, 2022AL, AZ, AR +47 more• Flowers Foods (Corporate Offices)

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

Tastykake Lemon Pie (Flowers) – Undeclared Soy (2022)

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Class IIModerate

FDAOct 7, 2022AL, AZ, AR +47 more• Flowers Foods (Corporate Offices)

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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