Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Oct
Summary
The FDA issued a Class II for Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3% by Johnson & Johnson Consumer, Inc.. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0847-2021
Action Date
2021-10-06
Status
Ongoing
Category
drug
Product Description
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7
Lot/Code Info: All lots within expiry
Quantity Affected: 196,380 cans
Reason for Recall
cGMP Deviations
Distribution
Nationwide in US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-14
Company
Skillman, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Johnson & Johnson Consumer, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Johnson & Johnson Consumer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Johnson & Johnson Consumer, Inc. have FDA actions?
Johnson & Johnson Consumer, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0847-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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