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Zee Cold Tabs (ULTRAtab) – Quality Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJan 26, 2022Nationwide• ULTRAtab Laboratories, Inc.

Polymyxin B Injection (AuroMedics) – Particulate Contamination (2022)

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Class IHigh

FDAJan 26, 2022Nationwide• AuroMedics Pharma LLC

Dicyclomine Tablets (Cardinal) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Back Relief II (ULTRAtab) – Manufacturing Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJan 26, 2022Nationwide• ULTRAtab Laboratories, Inc.

Triamterene-Hydrochlorothiazide (Cardinal) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Propranolol Tablets (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Estradiol Tablets (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Bumetanide Tablets (Cardinal) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

APAP 500mg Tablets (ULTRAtab) – Manufacturing Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJan 26, 2022Nationwide• ULTRAtab Laboratories, Inc.

Lisinopril/Hydrochlorothiazide Tablets (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Allopurinol Tablets (Cardinal Healthcare) – temperature deviation (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Amoxicillin Tablets (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Coated Back Relief Tablet (ULTRAtab) – Manufacturing Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJan 26, 2022Nationwide• ULTRAtab Laboratories, Inc.

Inhub Wixela (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

PredniSONE Tablets (Cardinal Healthcare) – temperature deviation (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Amoxicillin Suspension (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Terconazole Suppositories (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Aripiprazole Tablets (Cardinal Healthcare) – Temperature Exposure (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Folic Acid Tablets (Cardinal Healthcare) – temperature deviation (2022)

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class IIModerate

FDAJan 26, 2022Nationwide• CARDINAL HEALTHCARE

Dologen 325 Caplet (ULTRAtab) – manufacturing deviation (2022)

CGMP Deviations

Class IIModerate

FDAJan 26, 2022Nationwide• ULTRAtab Laboratories, Inc.

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