Why it was recalled
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
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
Lot numbers, UPCs & expiration codes
Lot # J146C, EXP 02-2019.
Where it was sold
distributed nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0231-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2017
- FDA report date
- Jan 31, 2018
- Quantity
- 21 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Odan Laboratories Ltd
Original FDA data
Every field from FDA enforcement report D-0231-2018, exactly as published.
Show all FDA fields
- City
- Pointe-Claire
- Status
- Terminated
- Country
- Canada
- Event ID
- 78887
- Address
- 325 Stillview Ave
- Code information
- Lot # J146C, EXP 02-2019.
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0231-2018
- Classification
- Class II
- Recalling firm
- Odan Laboratories Ltd
- Product quantity
- 21 jars
- Termination date
- Jun 18, 2018
- Reason for recall
- Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- distributed nationwide in the USA
- Recall initiation date
- Dec 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2018