FDA recall D-0755-2021

ANHUI WELCOME FOREIGN TRADE CO.,LTD. · Class II · drug

Product

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.

Distribution

Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.

Key facts

Status: Terminated
Initiation date: 2021-08-12
Report date: 2021-09-01
Termination date: 2021-12-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hefei, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0755-2021