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Recall Observatory FDA recall evidence

Drug product

Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218

D-1530-2019

April 01, 2019

Class III

Product summary

Firm
NingBo Huize Commodity Co.,Ltd.
Event
Event 83018
Status
Terminated
Classification
Class III
Quantity
52,160
Official record key
drug-enforcement:D-1530-2019

Official wording

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

Code information: Lot #: 20180601 Exp 5/31/2020, 20180604 Exp 6/3/2020, 20180820 Exp 8/19/2020, 20180821 Exp 8/20/2020, 20180822 Exp 8/21/2020

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