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Showing 481–500 of 11714 results

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Dr. Bump Pain Relief Gel (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Weh Weh Pain Relief Gel (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Mineral Sunscreen SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIModerate

FDAOct 10, 2025Nationwide• The Harvard Drug Group LLC

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Giant/Martin's Crunchy Taco Dinner Kit (Teasdale) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen - milk

FDAOct 10, 2025AL, CT, FL +8 more• Teasdale Foods, Inc.

Flawless Skin Fluid Moisturizer (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Shimmery Sun Lotion SPF 30 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Controlling Cream (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

YOU ARE SUNSHINE SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Sugared+Bronzed Sunscreen (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Everolimus Tablets (Endo) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Karina Daily Moisturizer (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Elixir Tinted Sunscreen (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Niacin Extended-release Tablets (Lannett) – dissolution failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAOct 10, 2025Nationwide• Lannett Company Inc.

Everolimus Tablets 2.5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Elixir Mineral Sunscreen SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Everolimus Tablets 5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

bk3500 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

bk3000 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

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