Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc
Summary
The FDA issued a Class II for Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, by Beiersdorf Inc. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0016-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Lot/Code Info: Lot# TN00857, exp. date 04/30/2023
Quantity Affected: 70,320 cans
Reason for Recall
cGMP Deviations
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-30
Company
Wilton, CT
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 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Beiersdorf Inc has 8 FDA actions in our database, including 8 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 (Beiersdorf Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beiersdorf Inc have FDA actions?
Beiersdorf Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0016-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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