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Digoxin Tablets 0.25mg (Marlex) – Label Mix-Up (2023)

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Class IIModerate

FDAAug 25, 2023Nationwide• Marlex Pharmaceuticals, Inc.

ChloraPrep Clear (CareFusion) – Stability Expiry Concerns (2023)

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

Class IIModerate

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Digoxin Tablets 0.25mg (Marlex) – Label Mix-Up (2023)

ChloraPrep Clear (CareFusion) – Stability Expiry Concerns (2023)

BBQ Sauce (Fresh Chile) – Undeclared Fish (2023)

Island Sauce (Somebody's Mother's) – Undeclared Soy (2023)

Sweet & Spicy BBQ Sauce (Fresh Chile Company) – Undeclared Fish (2023)

Doxil Injection (Baxter) – Temperature Exposure (2023)

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Fenugreek Capsules (Vitality Works) – Foreign material risk (2023)

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Fenugreek Capsules (Vitality Works) – Pen Fragments (2023)

Fenugreek Capsules (Vitality Works) – Pen Fragment (2023)

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Fenugreek Capsules (Vitality Works) – Pen Fragment (2023)

Fenugreek Capsules (Vitality Works) – Foreign material risk (2023)

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Fenugreek Capsules (Vitality Works) – Pen Fragment (2023)