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Recall Observatory FDA recall evidence

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

D-0755-2021

August 12, 2021

Class II

Product summary

Firm
ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Event
Event 88371
Status
Terminated
Classification
Class II
Quantity
63,750
Official record key
drug-enforcement:D-0755-2021

Official wording

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

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

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility cannot be assured