Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
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Reason Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Reason Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously…
Reason Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture…
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture…
Reason Subpotent Drug
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Reason Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization…
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility