Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a product labeled for eye use but not manufactured to ophthalmic sterility standards, creating a risk of serious ocular infection or injury. Although no illnesses have been reported, the hazard is material rather than theoretical, placing it in the High category.
Plain-English summary
Pi yen chin Ophthalmic Redness Reliever Drops, a 10 ml (0.34 fl oz) product made by ANHUI WELCOME FOREIGN TRADE CO., LTD. and distributed by International Nature Nutraceuticals, Inc. in New York, is being recalled.
The recall was initiated because the packaging labels the product as ophthalmic drops intended for eye use. However, the product is actually manufactured as nasal drops, and sterility cannot be assured for safe application to the eyes.
Approximately 63,750 units were distributed. Affected lot numbers include: Lot 180901 (expires 8/2021), Lot 190601 (expires 5/2022), Lot 191201 (expires 11/2022), Lot 200701 (expires 6/2023), Lot 201101 (expires 10/2023), and Lot 210501 (expires 4/2024).
Consumers who have purchased this product should stop using it immediately and consult a healthcare provider if they have already applied it to their eyes.
The recalled product
- 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
- Manufacturer
- ANHUI WELCOME FOREIGN TRADE CO.,LTD.
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- sterility-assurance
- mis-labeling
- eye-safety
Distribution
Distributed in 1 state:
- NY
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