Drug 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
D-0231-2018
Product summary
- Event
- Event 78887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 jars
- Official record key
drug-enforcement:D-0231-2018
Official wording
Reason: Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Code information: Lot # J146C, EXP 02-2019.
Distribution pattern: distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications