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
D-0232-2018
Product summary
- Event
- Event 78887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 179 kits
- Official record key
drug-enforcement:D-0232-2018
Official wording
Reason: Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Code information: Lots # J203, J204, EXP 02-2018; J228, J274, EXP 09-2018
Distribution pattern: distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications