August 2021 FDA Recall Drug by Anhui Welcome Foreign Trade Co.,ltd.
D-0755-2021 - Labeling

This Class II drug recall was voluntarily initiated by Anhui Welcome Foreign Trade Co.,ltd. on August 12, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A. and the recall is currently terminated.

Recall Number: D-0755-2021

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.
Initiated
08-12-2021
Reported
09-01-2021
Quantity
63,750

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-23-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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