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Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusiv...

FDA Recall #D-0755-2021 — Class II — August 12, 2021

Recall #D-0755-2021 Date: August 12, 2021 Classification: Class II Status: Terminated

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.

Recalling Firm

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

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

63,750

Distribution

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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