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Recall Observatory FDA recall evidence

Drug 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

D-1076-2018

August 03, 2018

Class III

Product summary

Firm
Huijing (Shanghai) Bio-tech Co., Ltd.
Event
Event 80753
Status
Terminated
Classification
Class III
Quantity
75,000 pads
Official record key
drug-enforcement:D-1076-2018

Official wording

Reason: Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.

Code information: Lot # 2458067, Exp 11/2019

Distribution pattern: Product was distributed to one distributor in VA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent