SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Reason Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility…
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved…
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved…
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved…
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