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Undeclared allergen; egg.
Product tested positive for Salmonella
Undeclared egg
Non-Sterility
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
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.
Product appears to be Yellow Oleander instead of Nuez de la India as labeled.
Products may be contaminated with Listeria monocytogenes.