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Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

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

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'

Class IIILow

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

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Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

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

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

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

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

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

Losartan Hydrochlorothiazide (Macleods) – Plastic Contamination (2024)

Zilretta Injection (Pacira) – Stability Specification Failure (2024)

Metoprolol Tablets (Rubicon) – Metal Contamination (2024)

Sirolimus Tablets (Dr. Reddy's) – Impurity Specification Failure (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Methylprednisolone Injection (Sagent) – Particulate Matter (2024)

Haloperidol Injection (Somerset) – Foreign Substance (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Tirzepatide (Revive Rx) – Labeling Mix-up (2024)