The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0231-2018·Announced 2018-01-31

Odan Laboratories Recalls Day Cream SPF15 Due to Stability Failure

Odan Laboratories is recalling 21 jars of Day Cream SPF15 because the product failed stability specifications at 12 months.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific issue is a stability failure, which is a quality control issue rather than a direct acute hazard like contamination or mislabeling of allergens.

Plain-English summary

Odan Laboratories Ltd is recalling 21 jars of Day Cream SPF15 Crème de jour FPS 15. The product is a 15 ml / 0.5 fl. oz jar containing Avobenzone 2%, Octinoxate 7%, and Oxybenzone 5%. It was made in Canada by Kamins Dermatologics Inc. and distributed nationwide in the USA.

The recall was initiated because the product failed stability specifications, specifically showing a stability failure at 12 months under long-term room temperature conditions. The affected lot number is J146C, with an expiration date of 02-2019.

Consumers who have this product should stop using it and contact the recalling firm for further instructions.

The recalled product

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…
Manufacturer
Odan Laboratories Ltd
Category
Drug — Topical Sunscreen
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # J146C
  • EXP 02-2019.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Odan Laboratories Ltd under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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