FDA recalls kids and baby sunscreen due to contamination

FDA recalls kids and baby sunscreen due to contamination
FDA
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Wednesday, September 25, 2013 - 10:22am

September 23, 2013 - W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion (lot # 3164A) due to microbial contamination. The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.

No adverse reactions have been reported in connection with these products.

Both sunscreens are sold in the USA & Canada online and at major retailers as well as independent food co-ops and pharmacies. This product can be identified by matching the UPC with the Lot code, which can be found on the top front of the tube crimp.

The affected lots include the following:

SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091&634084490114) Lot #’s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A
SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A
Consumers who have purchased the SPF 30 Baby Sunscreen Lotion should not use these products and may return product to the original point of purchase for a full refund, or contact Badger directly at 1-800-603-6100 or email recalls@badgerbalm.com between the hours of 8:30-4:30 ET, Monday - Friday.

Adverse events that may be related to the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm1
Regular Mail: use postage-paid, pre-addresses Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addresses form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

As a father and grandfather, the safety and well-being of children is my highest priority,” said Badger Founder & CEO Bill Whyte. “All of these lots passed the required microbiological and comprehensive challenge testing prior to sale. It was during routine re-testing that we discovered that the preservative system in several lots had been compromised. In our 18-year history, this voluntary recall is a first. We continue to conduct rigorous testing and are taking steps to ensure this doesn’t happen in the future.”

Badger sunscreen lotions are carefully formulated using only food-grade emulsifiers and natural preservatives that are gentle on the skin. All Badger sunscreen products have obtained top safety and efficacy ratings from the Environmental Working Group3 disclaimer icon and protect only with non-nano zinc oxide – the safest single active ingredient available.

W.S. Badger Co. Inc. manufacturers the No. 1 selling sunscreen in the U.S. Natural Markets, 1 and has produced quality, all-natural and certified organic body care products since 1995. Family owned and family run, Badger aims to protect, soothe and heal with ingredients safe for all. Badger has been awarded the B Corp Certification, after demonstrating its hard work to create a healthy business with ethical and charitable principles. Visit badgerbalm.com4 for more information.

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