FDA Drug Recalls

Recalls / Class II

Class IID-0832-2021

Product

Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858,

Affected lot / code info
All lots within expiry.

Why it was recalled

cGMP Deviations

Recalling firm

Firm
Johnson & Johnson Consumer, Inc.
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
199 Grandview Rd, N/A, Skillman, New Jersey 08558-1311

Distribution

Quantity
a) 223,884; b) 245,880 cans
Distribution pattern
Nationwide in US

Timeline

Recall initiated
2021-07-14
FDA classified
2021-09-24
Posted by FDA
2021-10-06
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0832-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.