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Showing 3041–3060 of 14370 results

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PAINAID BRF Back Relief (Ultra Seal) – Manufacturing Issues (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

PEPTIME Energy (Ultra Seal) – cGMP Issues (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

PEPTIME Energy Tablets (Ultra Seal) – Manufacturing Deviation (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

PAIN TERMINATOR Pain Relief (Ultra Seal) – Manufacturing Deviation (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

COLD TERMINATOR Decongestant (Ultra Seal) – cGMP Issues (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

PAINAID Tablets (Ultra Seal) – cGMP Issues (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

EXTRA STRENGTH UN-ASPIRIN (Ultra Seal) – cGMP Issues (2022)

cGMP deviations

Class IIModerate

FDAJan 24, 2022Nationwide• Ultra Seal Corporation

Proctofoam HC (Mylan) – cGMP Deficiencies (2022)

cGMP deficiencies

Class IIModerate

FDAJan 21, 2022Nationwide• Mylan Pharmaceuticals Inc

Azacitidine 1,00mg Vial (Dr. Reddy's) – Stability Failure (2022)

Failed stability specifications

Class IIILow

FDAJan 19, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Bortezomib 3.5mg Vial (Dr. Reddy's) – Stability Failure (2022)

Failed stability specifications

Class IIILow

FDAJan 19, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Azacitidine 100mg Vial (Dr. Reddy's) – Stability Failure (2022)

Failed stability specifications

Class IIILow

FDAJan 19, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Doxylamine Pyridoxine Tablets (Teva) – Dissolution Failure (2022)

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

Class IIModerate

FDAJan 18, 2022Nationwide• Teva Pharmaceuticals USA

Lexette Topical Foam (Mayne Pharma) – Dispensing Issue (2022)

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Class IIModerate

FDAJan 14, 2022Nationwide• Mayne Pharma Inc

Moxifloxacin Ophthalmic Solution (Aurobindo) – Impurity Issue (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 14, 2022Nationwide• Aurobindo Pharma USA Inc.

Metoprolol Succinate Tablets (Ascend) – Dissolution Failure (2022)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 12, 2022Nationwide• Ascend Laboratories, LLC

Sodium Bicarbonate Injection (Exela) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 11, 2022Nationwide• Exela Pharma Sciences LLC

Lung Cleaner (Pharmasol) – Manufacturing Deviation (2022)

cGMP deviations

Class IIModerate

FDAJan 11, 2022CO, IN• Pharmasol Corporation

Clobetasol Propionate Foam (Ingenus) – CGMP Issues (2022)

CGMP Deviations

Class IIModerate

FDAJan 10, 2022Nationwide• Ingenus Pharmaceuticals Llc

Tretinoin Capsules (Teva) – Dissolution Failure (2022)

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.

Class IIModerate

FDAJan 10, 2022Nationwide• Teva Pharmaceuticals USA

Clobazam Suspension (VistaPharm) – Stability Failure (2022)

Failed Stability Specifications

Class IIModerate

FDAJan 7, 2022Nationwide• VistaPharm, Inc.

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