Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Ch
Summary
The FDA issued a Class II for Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.3 by ANHUI WELCOME FOREIGN TRADE CO.,LTD.. Reason: Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility canno.
Details
Source
Drug Recall
External ID
D-0755-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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
Lot/Code Info: 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
Quantity Affected: 63,750
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-12
Company
Hefei, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ANHUI WELCOME FOREIGN TRADE CO.,LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ANHUI WELCOME FOREIGN TRADE CO.,LTD. have FDA actions?
This is the only FDA action we have on record for ANHUI WELCOME FOREIGN TRADE CO.,LTD. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0755-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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