Notice to Customers: Badger Sunscreen Lotion Recall

Notice from December 5, 2014: Badger offers a broad range of mineral sunscreen creams and lotions. In September 2013, we voluntarily recalled two of those products. The recall covered all manufactured lots of SPF30 Baby Sunscreen Lotion and select lots of SPF 30 Kids Sunscreen Lotion. Recalled lots from the SPF30 Baby and Kids Sunscreen Lotions may have been sold after the voluntary recall took effect. If you have purchased any Badger sunscreen lotion since the September 2013 recall, we encourage you to carefully check your product to make sure you do not have any of the recalled lotions. For complete information on the recall, including the affected lots and lot numbers, please see below.

September 24, 2013

Attn Badger Sunscreen Lotion Customers:

This is to inform you of a voluntary product recall involving:

UPC Code
Country
Product Name
Lot #
Contaminated*
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3024A
No
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3057A
No
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3063A
Yes
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3063B
No
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3132A
Yes
634084490091
USA
Badger SPF 30 Baby Sunscreen Lotion 4oz
3133A
Yes
634084490145
USA
Badger SPF 30 Kids Sunscreen Lotion 4oz 
3164A
Yes


If you purchased the product in Canada please use these UPCs & Lot #s.

UPC Code
Country
Product Name
Lot #
Contaminated*
634084490114
Canada
Badger SPF 30 Baby Sunscreen Lotion 4oz
3057A
No
634084490114
Canada
Badger SPF 30 Baby Sunscreen Lotion 4oz
3132A
Yes
634084490169
Canada
Badger SPF 30 Kids Sunscreen Lotion 4oz 
3164A
No


*Even though only three of six lots of our SPF30 Baby Sunscreen Lotion showed contamination, we are recalling all lots, even those that showed no contamination, as a precaution. We are only recalling the one affected lot of our SPF30 Kids Sunscreen Lotion.

This voluntary recall has been initiated due to microbial contamination. The products were tested and isolated lots were found to be contaminated with the bacterium Pseudomonas aeruginosa and/or the fungi Candida parapsilosis, Candida xestobii, Fusarium oxysporum lycopersici. The fungus Acremonium was found in some samples but not in any products sent to customers. See below for a toxicological summary and to view the full toxicology report.

Badger has worked with a Board-Certified pediatrician who has prepared a report and answered questions on the potential health risks associated with the use of sunscreen products possibly contaminated with Pseudomonas aeruginosa (PA), Candida parapsilosis (CP) and Acremonium Fungi (AF). See below for a summary of the pediatrician's findings and to view the full report.

The above recalled lots passed all pre-production challenge testing and initial microbiological testing prior to sale, but during a routine quality check, microbial contamination was identified in select lots, which is why we are initiating the voluntary recall of the above products/lots.

We began shipping the recalled lots to stores and individuals as early as February, 2013.

The lot code can be found on the top front
of the tube crimp as shown to the left.



If you have purchased one of the lots that is being recalled, please return the product to the original point of purchase for reimbursement or contact Badger directly:

Customer Service Team
recalls@badgerbalm.com
Toll Free: 800-603-6100
Phone: 603-357-2958

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:

This recall is being made with the knowledge of the Food and Drug Administration.



Message from the CEO:

I wanted to personally apologize for this recall. We Badgers put great effort into making exceptional products and I'm so sorry that we fell short on this one. One Facebook inquiry asked for a "plain English" explanation and I wrote the following in response: My understanding of the toxicologist's report is that the "organisms" found in the failed products are also commonly found in the environment and on our skin. They are unlikely to cause problems except for in immune-compromised persons or for persons with severely damaged skin. We used these sunscreens all summer long for my three year old granddaughter and I was concerned when I first found out about the problem, but the toxicologist's and pediatrician's reports reassured me. I'm very sorry this happened and we will do everything in our power to see that this never happens again. By the way, to be on the safe side, we recalled all of the lots of SPF30 Baby Sunscreen Lotions although only a few of them were found to be compromised. My short answer is, for normally healthy persons, this should not have caused any problem.
 
Bill_Signiture.png
Bill Whyte
CEO & Head Badger
W.S. Badger Company, Inc.



Questions about the Recall
- Answers from Badger
(click question for answer)


View the full toxicology report here!

Which products are voluntarily being recalled?

Only a select few lots of SPF 30 Kids and Baby Sunscreen Lotion are being voluntarily recalled. See full list of Products and Lot codes (and where to find the Lot # on your product) above.

I've already used some of the product(s). Should I be concerned?

According to the Pediatrician's report: It is important to emphasize that it would be very unusual for any babies, children or families exposed to the very small number of contaminated lots of these products to have any medical consequences. Any possible infections or reactions from PA, CP and AF would be rare or very unusual (depending upon the organism and circumstances) if used according to Badger's package labeling. Though some infections are possible even with intact skin, they would be very unusual. See below for more health related questions answered by the pediatrician or read the pediatrician's full report.

What does the Toxicological Report say?

According to the toxicological report: The microbes in question, Pseudomonas aeruginosa (a bacterium), Candida parapsilosis (a fungus), Candida xestobii (a fungus), and Fusarium oxysporum lycopersici (a fungus) are commonly found throughout the natural environment and are not considered to be dangerous. There is very little chance that products contaminated with these would cause any ill health effects when used on healthy skin as directed. There is a possible risk of infection if you applied this to damaged skin or an open wound or if your immune system was compromised. The probability of serious adverse health consequences is remote and any potential health effects would be temporary and reversible. While unlikely, there is a health concern and this is determined to be a level II recall. Click here to read the full toxicological report.

Acremonium, a common soil fungus rarely affecting humans, was found in only one sample that had been contaminated after being opened and handled. None of the sealed products sent to customers were shown to contain this microbe.

What are the details of the proactive voluntary recall?

We Badgers believe in transparency and education. In our 18-year history, this is our first voluntary recall, which we have undertaken as a precaution due to third-party lab re-testing results that showed evidence of preservative instability in the two aforementioned products. The cause of the natural preservative breakdown is being investigated, and Badger will post conclusive findings on its website once results are available.

How does Badger plan to prevent this from happening again?

Once this problem was discovered, we commissioned a full investigation, including independent toxicology and microbiology assessments. The results of these assessments led to our decision to issue a voluntary recall. Going forward, we will be reformulating our sunscreen lotions to strengthen the preservative system and will be improving manufacturing processes to ensure we don't have a problem like this again.

Are any other Badger products affected?

No other Badger products are affected. We rigorously and routinely test all of our products. Badger is committed to creating outstanding products that are safe for human skin, and for our fragile environment. We will continue to do so by using the highest quality natural and organic ingredients and by ensuring that all Badger products perform as promised. This comprehensive voluntary recall represents taking an extremely cautious approach beyond what is required or expected by the FDA. We have taken this approach because it is the right thing to do, and that is our Badger way.

What do I do with the recalled product?

If you have purchased one of the lots that is being recalled, please return the product to the original point of purchase for reimbursement or contact Badger directly:

Customer Service Team
recalls@badgerbalm.com
Toll Free: 800-603-6100
Phone: 603-357-2958

PO Box 58/768 Route 10
Gilsum, NH 03448



Questions about Health Concerns - Answers from Dr. Jeffrey P. Bomze, M.D., F.A.A.P. (click question for answer)


View the full pediatrician's report here!

Is this a serious or minor health risk to me, or my child?  Should I be worried?

I do not believe that this is a serious health matter for a parent or child. There is a possible, but very unlikely concern, if they have a serious underlying illness that alters their immunity, have tubes in their body because of a serious underlying illness or problem or have had a long hospitalization, major surgery, open wounds or burns AND HAVE SIGNS OR SYMPTOMS on their skin or body. This would also require the lotion to be in contact with areas of the body (eyes, mouth, lips, genital area, and anal area) where sunscreen would not be applied.

Are these microbes found in the two recalled Badger products disease causing?

It is very unlikely that anything at all will occur as a result of using the potentially contaminated sunscreen products. It is possible that minor skin infections or other minor infections may occur, but they are readily treated and very unlikely to cause any lasting problems.

It is possible, but very unlikely, that a more serious infection may occur, but it would be extremely unlikely in a healthy child and with proper use of the product. More serious infections would be very unusual and would almost always occur in children with underlying serious health problems and other risk factors.

Can anything be transmitted from me, or my child, to others?

Other than possible spread person-to-person primarily in hospital settings, person-to-person infection would be rare, if at all.

What might be the possible symptoms/reactions caused by the recalled products?

Note from Badger: As stated in the pediatrician's report it is highly unlikely that the microbes found in the select lots of sunscreens would cause any reactions, and each of these symptoms/reactions below may very well have been caused by factors unrelated to contaminated sunscreens.

     • Skin rashes or lesions –neck or skinfolds under arms (possibly), diaper area, groin, and on the buttocks
       (unlikely since these areas typically don't come into contact with sunscreen.)

     • Rashes or lesions in mouth/throat, genital/vaginal areas, anal area (unlikely since these areas typically don't
       come into contact with sunscreen
.)

     • Nail lesions (unlikely to apply sunscreen to hands of infants and children (prevent licking it off)

     • Eye redness – (unlikely to have applied sunscreen around/near eyes)

     • Swelling, redness or pain in the skin or under the skin

     • Cough or breathing difficulty – very unlikely

     • Urinary frequency and pain or cloudy urine in toilet-trained children (very unlikely – would not apply sunscreen
       to genitals or diaper/bathing suit areas
)

How long after applying would I see a reaction, if any?

Reactions would occur within a few days or after several weeks (most likely in a matter of days for minor and common rashes or infections.)

Do I need to see my health care provider/doctor, or take my child to be seen by a pediatrician?

If the product was used on healthy skin as directed, and it has been weeks or more since use of the product that may be contaminated, then it is very unlikely that there would be any reaction. If potentially contaminated product was used on healthy skin as directed and a reaction appears within days to a week or more, you should consult a doctor. If the product was used on immune-compromised persons with a history of a serious illness, chronic illness, including recent and prolonged hospitalization, recent surgery, open wounds or burns, you should consult a doctor. Fever alone is not a reason to call or to be seen. If a fever is present along with above signs or symptoms in an infant or child with underlying medical problems, then the child should be seen by a doctor.

What information should I share with my health care provider/doctor/pediatrician?

You should call your health care provider if you have any concerns about new skin rashes, changes in areas exposed to the sunscreens or there are any other changes in your child, which concern you. You should let them know that you used Badger sunscreen products and also inform them of any medications, exposures and signs or symptoms present in your child. You should also let them know when you used the sunscreen, how often you used it and inform them that there was a voluntary recall because of possible contamination with certain microbiologic organisms. Let them know that they can look at the company's website or call for further information.

What is meant, specifically, by “open wound”?

An open wound is a wound that has not healed, and is not covered over by new healed tissue and skin. It is usually red/purple in the unhealed areas. Any drainage, foul odor or swelling, redness and/or pain in the surrounding area is a concern for infection.

Would hives be one of the potential health affects?

Hives would not be a result of infection/exposure to any of these organisms. Hives are primarily an acute, allergic response to something-contact or systemic exposure.

What are the lasting health effects, if any?

If used properly and in healthy infants and children, you would not expect lasting effects. In the very unlikely event a more significant rash or infection occurred as a result of use of these products in a healthy infant or child, it would very likely be treated and no lasting effects would be expected. In the very rare circumstance where an infant or child has a significant risk from major underlying problems, it could lead to damage of any areas infected.



Join the conversation about the recall on Facebook.