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Showing 501–520 of 1571 results

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Guaifenesin Codeine Solution (PAI Holdings) – Superpotent Preservative (2025)

Superpotent; sodium benzoate preservative

Class IIILow

FDAJan 7, 2025OH• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Clobazam Tablets (Amerisource) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAJan 7, 2025Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 60mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 20mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 30mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Metformin ER Tablets 500mg (Granules) – foreign tablet found (2024)

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Class IIModerate

FDADec 30, 2024IN, OH• Granules Pharmaceuticals Inc.

Progesterone Injection 500mg (Eugia) – glass piece contamination (2024)

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Class IIModerate

FDADec 27, 2024Nationwide• Eugia US LLC

Prograf 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Class IHigh

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

Astagraf XL 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Class IHigh

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

Adrenalin Nasal Solution (ENDO) – misleading label (2024)

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

Class IHigh

FDADec 20, 2024Nationwide• ENDO USA, Inc.

Levothyroxine Tablets 75mcg (Lupin) – impurity specification (2024)

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Class IIModerate

FDADec 20, 2024IN, OH• Lupin Pharmaceuticals Inc.

Methadone Tablets 5mg (West-Ward) – illegible identification (2024)

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

Class IIILow

FDADec 19, 2024Nationwide• West-Ward Columbus Inc

Medroxyprogesterone Injection (Eugia) – CGMP deviation (2024)

CGMP Deviations

Class IIModerate

FDADec 18, 2024Nationwide• Eugia US LLC

GlipiZIDE Extended-Release Tablets (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

FOUZEE SugarLin Herbal Capsules (Shoppers-Plaza) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

Class IHigh

FDADec 16, 2024Nationwide• SHOPPERS- PLAZA

Ciprofloxacin Ophthalmic Solution (FDC Limited) – Defective Container (2024)

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDADec 16, 2024Nationwide• FDC Limited

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Class IIILow

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Class IIILow

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

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