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Recall Observatory FDA recall evidence

Drug product

Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.

D-1564-2019

April 01, 2019

Class III

Product summary

Firm
NingBo Huize Commodity Co.,Ltd.
Event
Event 83018
Status
Terminated
Classification
Class III
Quantity
126,500
Official record key
drug-enforcement:D-1564-2019

Official wording

Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Code information: Lot #: 20170410, Exp 04/09/2019; 20170515, Exp 05/14/2019; 20170516, Exp 05/15/2019; 20170517, Exp 05/16/2019; 20170518, Exp 05/17/2019; 20170519, Exp 05/18/2019; 20170522, Exp 05/21/2019; 20170523, Exp 05/22/2019: 20170524, Exp 05/23/2019; 20170525, Exp 05/24/2019; 20170526, Exp 05/25/2019; 20180615, Exp 06/14/2020

Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations