Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB
Summary
The FDA issued a Class II for Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tec by ARG Laboratories, Inc.. Reason: Out of Specification for active ingredient.
Details
Source
Drug Recall
External ID
D-0522-2024
Action Date
2024-06-05
Status
Ongoing
Category
drug
Product Description
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
Lot/Code Info: Lot 08623C2, 08923C2, Exp 03/31/2026
Quantity Affected: 9,697
Reason for Recall
Out of Specification for active ingredient
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-17
Company
Dallas, TX
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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ARG Laboratories, Inc. has 11 FDA actions in our database, including 11 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 (ARG Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARG Laboratories, Inc. have FDA actions?
ARG Laboratories, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0522-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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