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Showing 781–800 of 14370 results

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Dianeal Low Calcium Dialysis Solution (Baxter) – Sterility Risk (2024)

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Class IIModerate

FDAJun 17, 2024Nationwide• Baxter Healthcare Corporation

Methylphenidate Hydrochloride (Trigen) – Dissolution Failure (2024)

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Class IIModerate

FDAJun 17, 2024Nationwide• Trigen Laboratories

Zilretta (Pacira) – Dissolution Specifications (2024)

Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

Class IIModerate

FDAJun 12, 2024Nationwide• PACIRA PHARMACEUTICALS INC

Allopurinol Tablets (Dr. Reddy's) – Foreign Substance (2024)

Presence of foreign substance.

Class IIModerate

FDAJun 7, 2024IL, MS, OH• Dr. Reddy's Laboratories, Inc.

Eszopiclone Tablets (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Related Substances

FDAJun 4, 2024MS, OH• Dr. Reddy's Laboratories, Inc.

Amoxicillin Chewable Tablets (Teva) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJun 4, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Thyroid Formula Capsules (Penn Herb) – Salmonella risk (2024)

Potential Salmonella contamination

FDAJun 3, 2024CA, FL, IL +7 more• Penn Herb Company, Ltd.

Phenazopyridine HCl Tablets (RemedyRepack) – Product Mix Up (2024)

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class IIModerate

FDAMay 31, 2024Nationwide• RemedyRepack Inc.

Cefixime Oral Suspension (Lupin) – Content Uniformity Failed (2024)

Failed Content Uniformity Specifications

Class IIModerate

FDAMay 30, 2024Nationwide• Lupin Pharmaceuticals Inc.

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Phenazopyridine HCl Tablets (Winder) – Product Mix Up (2024)

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class IIModerate

FDAMay 28, 2024Nationwide• Winder Laboratories, LLC

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Dexamethasone Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Class IIModerate

FDAMay 23, 2024Nationwide• Eugia US LLC

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