FDA recall D-0232-2018

Odan Laboratories Ltd · Class II · drug

Product

Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4

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-0232-2018