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Showing 701–720 of 1639 results

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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

Eptifibatide Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

FDAMay 22, 2024Nationwide• Eugia US LLC

Buprenorphine Hydrochloride Injection (Pfizer) – Crimp Seal Issue (2024)

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class IIModerate

FDAMay 20, 2024Nationwide• Pfizer Inc.

Labetalol Hydrochloride Injection (Pfizer) – Crimp Seal Issue (2024)

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class IIModerate

FDAMay 20, 2024Nationwide• Pfizer Inc.

Acetaminophen Tablets (Contract Pharmacal) – Tablet Discoloration (2024)

Discoloration: Brownish tablets

Class IIModerate

FDAMay 20, 2024MI• Contract Pharmacal Corporation

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

FDAMay 16, 2024Nationwide• Rising Pharma Holding, Inc.

Epinephrine-Lidocaine Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Dexamethasone-Moxifloxacin Suspension (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Epinephrine-Lidocaine Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Prednisolone-Moxifloxacin Suspension (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Klarity-C Ophthalmic Emulsion (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Dexamethasone-Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Rizatriptan Tablets (Glenmark) – Impurity Concern (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

Cephalexin Suspension 125mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

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