Recalls / Class II
Class IID-0590-2018
Product
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
- Affected lot / code info
- Lot#: 7N04CS, 7N05CS, Exp. 11/2019
Why it was recalled
Labeling: Label mix-up
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 528 units
- Distribution pattern
- Arkansas only
Timeline
- Recall initiated
- 2018-02-23
- FDA classified
- 2018-03-12
- Posted by FDA
- 2018-03-14
- Terminated
- 2020-01-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0590-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.