PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 1, 2021 Initiated: August 12, 2021 #D-0755-2021

Product Description

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

Reason for Recall

Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.

Details

Units Affected
63,750
Distribution
Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.
Location
Hefei, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by ANHUI WELCOME FOREIGN TRADE CO.,LTD.. Units affected: 63,750.
Why was this product recalled?
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0755-2021.