Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5...

FDA Recall #D-0231-2018 — Class II — December 20, 2017

Recall #D-0231-2018 Date: December 20, 2017 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Odan Laboratories Ltd — Pointe-Claire, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

21 jars

Distribution

distributed nationwide in the USA

Code Information

Lot # J146C, EXP 02-2019.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated