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Cosmetics

Updated: May 27, 2022 11:00 AM
Henkel Corporation (“Henkel”) is voluntarily recalling 180 bottles of its 4.2 ounce Alterna Bond Repair Leave-in Heat Protection Spray, because it has the potential to be contaminated with Burkholderia cepacia complex (Bcc), which poses little medical risk to healthy people, but can cause an increased risk for... See More illness or infection in people who have certain health problems, such as weakened immune systems, chronic lung diseases, chronic granulomatous disease, or wound infections. Henkel has received no reports of harm or injury in connection with this product.

Patients with underlying lung disease (especially cystic fibrosis) might be at increased risk for severe infections with Bcc. The potential for product contamination was noted after testing performed by Henkel revealed the presence of Bcc in some 4.2 ounce bottles of Alterna Bond Repair Leave-in Heat Protection Spray.

The Alterna Bond Repair Leave-in Heat Protection Spray included in this recall comes in a 4.2 ounce, purple plastic spray bottle marked with lot # Y401427403 on the bottom, and was distributed nationwide through a distributor. The product was available for sale to the public no earlier than April 12, 2022.

The consumers who have purchased the applicable 4.2 ounce bottles of Alterna Bond Repair Leave-in Heat Protection Spray described above are urged to return them to their place of purchase for a full refund.

Consumers with questions about this recall may contact Henkel's customer specialists at 1-888-4ALTERNA (1-888- 425-8376). This customer service line is operational Monday through Thursday from 6:00 a.m. to 4:00 p.m. PST, and Friday from 6:00 a.m. to 2:00 p.m. PST.

If you have experienced any symptoms, or have any medical questions associated with this product, it is important to report it. It can help to prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Henkel Corp.
Brand name: Alterna
Product recalled: Leave-in heat protection spray
Reason of the recall: Potential to be contaminated with Burkholderia cepacia complex.
FDA Recall date: May 27, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/henkel-corp-voluntarily-recalls-alternar-bond-repair-leave-heat-protection-spray-due-possible-health
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Babyganics is voluntarily recalling two lots of 20-ounce bottles of babyganics® 20oz chamomile verbena bubble bath, due to the presence of the bacterium Pluralibacter gergoviae. The products were sold in the last two months only at select retailers in the U.S.

During internal testing related to product... See More shelf life across the Babyganics bubble bath line, it was discovered that two specific lot numbers of this product contained the bacterium. While infants may be more susceptible than adults, Pluralibacter gergoviae does not usually cause healthy individuals to become sick. However, it may pose a risk of infection to those who are immunocompromised or have broken or irritated skin, such as diaper rash.

The only products affected are babyganics® 20oz chamomile verbena bubble bath UPC 8 13277 01375 4 with lot codes Y314 and Y315 found at the bottom of the packaging and contained in a white plastic bottle with a green plastic lid.

The testing confirmed that no other Babyganics products contained this bacterium. Babyganics takes pride in its commitment to vigorous consumer safety standards and providing peace of mind for parents, which is why the decision was made to voluntarily recover these bottles from retailers and to proactively reach out to consumers. Consumers with the affected product will be provided with a full refund after submitting their product and contact information at the company website. Consumers who have come into contact with the affected product and aren’t feeling well should contact their doctor.

Company name: Babyganics
Brand name: Babyganics
Product recalled: Chamomile verbena bubble bath
Reason of the recall: Presence of the bacterium Pluralibacter gergoviae, a bacterium
FDA Recall date: April 20, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/babyganics-issues-voluntary-recall-select-lots-babyganicsr-20oz-chamomile-verbena-bubble-bath
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Kao USA conducts voluntary recall of Jergens® Ultra Healing Moisturizer, issued 11-Mar-2022 by Kao USA Inc. over PR Newswire, the company advised that in the 'IDENTIFYING THE AFFECTED PRODUCTS' section, two lot codes have been added to the 3 oz size section ("ZU722861" and "ZU722871"). The complete,... See More corrected release follows: Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product.

Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections. Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure. Further investigation to determine the scope of the issue is still ongoing.

The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer. Only specific lots of the 3 oz and 10 oz sizes are affected.

IDENTIFYING THE AFFECTED PRODUCTS Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted. 

The affected lot codes for the 3 oz size can be found on the back of the bottle printed in black ink and begin with the prefix "ZU": 

ZU712851 ZU712911
ZU712861 ZU722851
ZU712871 ZU722881
ZU712881 ZU722861
ZU722871

The affected lot codes for the 10 oz size can be found on the bottom of the bottle printed in black ink and begin with the prefix "ZU":  

ZU722741  ZU732791 
ZU722771  ZU732801 
ZU722781 ZU732811 
ZU732781 ZU732821

Brand name: Jergens
Product recalled: Ultra Healing Moisturizer
Reason of the recall: Presence of Pluralibacter gergoviae, a bacterium
FDA Recall date: March 23, 2022
Company name: Kao USA Inc.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kao-usa-conducts-expanded-voluntary-recall-jergensr-ultra-healing-moisturizer
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Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product. Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a... See More bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections.

Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure. Further investigation to determine the scope of the issue is still ongoing. However, Kao USA Inc. promptly took the precautionary step of issuing a voluntary recall of the affected product by removing the product in question from warehouses, working with retailers to ensure the product is removed from store shelves, and proactively notifying consumers.

The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer. Only specific lots of the 3 oz and 10 oz sizes are affected.

IDENTIFYING THE AFFECTED PRODUCTS:
- Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted.
- The affected lot codes for the 3 oz size (UPC 019100109971 for single bottles and 019100267114 for pack of 3) can be found on the back of the bottle printed in black ink and begin with the prefix "ZU": ZU712851 | ZU712871 | ZU712911 | ZU722881 | ZU712861 | ZU712881 | ZU722851
- The affected lot codes for the 10 oz size (UPC 019100109988) can be found on the bottom of the bottle printed in black ink and begin with the prefix "ZU": ZU722741 | ZU722781 | ZU732791 | ZU732811 | ZU722771 | ZU732781 | ZU732801 | ZU732821

Anyone who has product from a recalled lot should call the Kao USA Inc. Consumer Care Center. A postage paid label and plastic bag will be sent to consumers via mail to easily return the product.

Company name: Kao USA Inc.
Brand name: Jergens
Product recalled: Ultra Healing Moisturizer
Reason of the recall: Presence of Pluralibacter gergoviae, a bacterium
FDA Recall date: March 18, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kao-usa-conducts-voluntary-recall-jergensr-ultra-healing-moisturizer
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Company name: Becca Cosmetics
Brand name: Becca Cosmetics
Product recalled: Light Shifter Brightening Concealer
Reason of the recall: Potential Mold
FDA Recall date: May 07, 2020
Recall details: Company Announcement Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca... See More Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation.

To date, no adverse reactions or injuries have been reported. This product was manufactured in the United States and distributed nationwide. The below are the details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.

- Product Name: Becca Cosmetics Light Shifter Brightening Concealer
- Batch: 0030A, 9308A, 0052A, 0052C, 9291A, 9309A, 0036A, 0037A, 0038A, 0038B, 0041A, 9289A, 0062A, 0062B, 0062C, 9283A, 9284A, 9287A, 9288A
- Size: 3.2 mL (only size available)
- Product Description: Concealer wand with silver overlay, and a white secondary carton
- UPC: 9331137030037, 9331137030044, 9331137030051, 9331137030068, 9331137030075, 9331137030099, 9331137030082, 9331137030105

If you have this product, please stop using it and contact the place of purchase regarding a refund. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/becca-cosmetics-voluntarily-recalls-light-shifter-brightening-concealer

Source: FDA
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Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

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Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca/en/alert-recall/folic-acid-1mg-affected-lots-exceed-or-may-exceed-acceptable-intake-limit-n-nitroso
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On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or... See More the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

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Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. The labeling will be updated to state the following:
1- New Contraindication:
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

2- Updated Warning:
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets. If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Sleepnet Corporation
Brand name: Mojo, Mojo 2, iQ 2, Phantom 2
Product recalled: CPAP and BIPAP Masks with Magnets
Reason of the recall: Potential interference with certain medical implants
FDA Recall date: March 18, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference
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