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NEOGEN-D (Pharma-Natural) – CGMP Deviation (2019)

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Class IIModerate

FDAJun 21, 2019Nationwide• Pharma-Natural Inc.

TUSSLIN Medication (Pharma-Natural) – manufacturing deviation (2019)

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Class IIModerate

FDAJun 21, 2019Nationwide

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NEOGEN-D (Pharma-Natural) – CGMP Deviation (2019)

TUSSLIN Medication (Pharma-Natural) – manufacturing deviation (2019)

Double Tussin DM (Pharma-Natural) – manufacturing deviation (2019)

Army Health Curcumin Pain Reliever (Pharma-Natural) – CGMP Deviation (2019)

Turbo Drops Enhanced (RXQ Compounding) – Sterility Concern (2019)

Prednisolone Moxifloxacin Ophthalmic Solution (RXQ Compounding) – sterility concern (2019)

Turbo Drops (RXQ Compounding) – Sterility Concern (2019)

Mineral Spring Water (Penafiel) – Arsenic Levels (2019)

Giorgio Baby Bella Mushrooms (C & S) – Temperature Concern (2019)

Taylor Farms Organic Baby Lettuce Mix – Temperature Issue (2019)

Cetirizine Oral Solution (P&L Developments) – cGMP Deviation (2019)

Cetirizine HCL Oral Solution (P&L Developments) – cGMP Deviation (2019)

Cetirizine Oral Solution (P&L Developments) – cGMP Deviation (2019)

Cough Syrup (Torrent) – bacterial contamination (2019)

Pseudoephedrine Oral Solution (Torrent Pharma) – Bacterial Contamination Risk (2019)

Memantine Oral Solution (Torrent Pharma) – Bacterial Contamination Risk (2019)

Diphenhist Oral Solution (Torrent Pharma) – Potential Contamination (2019)

Allergy Liquid Antihistamine (Torrent Pharma) – Potential Contamination (2019)

Nasal Decongestant Liquid (Torrent) – bacterial contamination (2019)

Cough Syrup (Torrent Pharma) – Bacterial Contamination Risk (2019)