FDA recall D-1533-2019

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

Reason for recall

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

Distribution

Foreign manufacturer located in China and distributed to seven consignees located in China.

Key facts

Status

Terminated

Initiation date

2019-04-01

Report date

2019-08-07

Termination date

2023-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Yuyao, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1533-2019