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Showing 701–720 of 1571 results

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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

Klarity-C Ophthalmic Emulsion (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

Moxifloxacin 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

Dexamethasone-Moxifloxacin Injection (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

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

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

Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

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

Class IIModerate

FDAMay 10, 2024CA, CT, FL +2 more• Preferred Pharmaceuticals, Inc.

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.

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 10, 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: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

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

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 10, 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' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

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

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