Multi-event December 2017 FDA Recall Drug by Odan Laboratories Ltd
This Multi-event Class II drug recall was voluntarily initiated by Odan Laboratories Ltd on December 20, 2017 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0231-2018
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
12-20-2017
01-31-2018
21 jars
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Odan Laboratories Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
distributed nationwide in the USA
06-18-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# J146C, EXP 02-2019.
Recall Number: D-0232-2018
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
12-20-2017
01-31-2018
179 kits
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Odan Laboratories Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
distributed nationwide in the USA
06-18-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots # J203, J204, EXP 02-2018; J228, J274, EXP 09-2018
