August 2018 FDA Recall Drug by Huijing (shanghai) Bio-tech Co., Ltd. (D-1076-2018 - Subpotent drug)
This Class III drug recall was voluntarily initiated by Huijing (shanghai) Bio-tech Co., Ltd. on August 3, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in Product was distributed to one distributor in VA and the recall is currently terminated.
Recall Number: D-1076-2018
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
08-03-2018
08-22-2018
75,000 pads
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Huijing (Shanghai) Bio-tech Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one distributor in VA
12-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
Batch or Lot Expiration Information
Lot# 2458067, Exp 11/2019
