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Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Undeclared egg
The firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Possible contamination with Salmonella spp.
Undeclared whey (milk), wheat flour, & bran (wheat); no nutrition fact panel & no contains statement
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Presence of Particulate Matter
Listeria monocytogenes
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.