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 II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
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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