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Showing 541–560 of 14362 results

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Clobazam Tablets (Amerisource) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAJan 7, 2025Nationwide• Amerisource Health Services LLC

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

Superpotent; sodium benzoate preservative

Class IIILow

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

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 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.

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

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.

Cardura XL 8mg (Viatris) – impurity specification failure (2024)

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Class IIModerate

FDADec 23, 2024Nationwide• Viatris Inc

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.

Cardura XL 4mg (Viatris) – impurity specification failure (2024)

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Class IIModerate

FDADec 23, 2024Nationwide• Viatris 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.

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.

Ketamine Injection 50mg (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA 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

Alpha Test (Iovate) - Cathine Presence (2024)

Presence of cathine in product

Class IIModerate

FDADec 18, 2024AZ, CA, CO +27 more• Iovate Health Sciences USA Inc.

Colchicine Capsules 0.6mg (Granules) – dissolution failure (2024)

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Class IIModerate

FDADec 18, 2024Nationwide• Granules Pharmaceuticals Inc.

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

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

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