FDA recall D-0231-2018

Product

Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0

Reason for recall

Failed Stability Specifications:stability failure at 12 months, long term RT conditions.

Distribution

distributed nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-12-20

Report date

2018-01-31

Termination date

2018-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pointe-Claire, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2018