Recalls / Class I
Class ID-0012-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
- Affected lot / code info
- Lot# TN0083J, exp. date 01/31/2023 TN0083K, exp. date 01/31/2023
Why it was recalled
Chemical contamination; presence of benzene
Recalling firm
- Firm
- Beiersdorf Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 45 Danbury Rd, N/A, Wilton, Connecticut 06897-4405
Distribution
- Quantity
- 124,668 cans
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-09-30
- FDA classified
- 2021-10-15
- Posted by FDA
- 2021-10-27
- Terminated
- 2023-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.