Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
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 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…
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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