D-0755-2021 Class II Terminated

Recalled by ANHUI WELCOME FOREIGN TRADE CO.,LTD. — Hefei, N/A

Recall Details

Product Type
Drugs
Report Date
September 1, 2021
Initiation Date
August 12, 2021
Termination Date
December 23, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63,750

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.

Distribution Pattern

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

Code Information

Lot 180901 Exp: 8/2021 Lot 190601 Exp: 5/2022 Lot 191201 Exp: 11/2022 Lot 200701 Exp:6/2023 Lot 201101 Exp: 10/2023 Lot 210501 Exp: 4/2024