Why it was recalled
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
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 numbers, UPCs & expiration codes
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
Where it was sold
Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0755-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 63,750
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Original FDA data
Every field from FDA enforcement report D-0755-2021, exactly as published.
Show all FDA fields
- City
- Hefei
- Status
- Terminated
- Country
- China
- Event ID
- 88371
- Address
- Changhe Kechuang Mansion Room 1602
- Address (line 2)
- No. 677 Changjiang West Rd
- 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
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0755-2021
- Classification
- Class II
- Recalling firm
- ANHUI WELCOME FOREIGN TRADE CO.,LTD.
- Product quantity
- 63,750
- Termination date
- Dec 23, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.
- Recall initiation date
- Aug 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021