FDA Drug Recalls

Recalls / Class II

Class IID-0840-2021

Product

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7

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
405,264 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-0840-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.