FDA Recall D-0831-2021

Johnson & Johnson Consumer, Inc. · Skillman, NJ

Class II Ongoing 1765 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9

Lot / code: All lots within expiry.

Quantity: 134,280 cans

Reason for recall

cGMP Deviations

Recall record

Recall number: D-0831-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in US
Recall initiated: 2021-07-14
Classified by FDA Center: 2021-09-24
FDA published: 2021-10-06
Recalling firm: Johnson & Johnson Consumer, Inc.
Firm location: Skillman, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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