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Recall Observatory FDA recall evidence

Drug product

festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China

D-1533-2019

April 01, 2019

Class III

Product summary

Firm
NingBo Huize Commodity Co.,Ltd.
Event
Event 83018
Status
Terminated
Classification
Class III
Quantity
20, 000
Official record key
drug-enforcement:D-1533-2019

Official wording

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

Code information: Lot #: 20181008, Exp 10/07/2020; 20181009, Exp 10/08/2020

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