Category: Health, Beauty, Wellness

For Immediate Release

September 5, 2018

Contact

Consumers

Beaumont Bio Med
 recall@naturalief.com
 800-332-2249

Announcement

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

Risk Statement: The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, Beaumont Bio Med has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

August 29, 2018

Contact

Consumers

HelloLife, Inc.
 1-616-803- 7243

Announcement

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, HelloLife, Inc. has not received any reports of adverse events related to the recalled products. (more…)

For Immediate Release

August 24, 2018

Contact

Consumers

Living Well Remedies, LLC
CustomerCare@LivingWellRemedies.com
800-249-7705

Announcement

FOR IMMEDIATE RELEASE – Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. Living Well Remedies, LLC has n (more…)

For Immediate Release

August 27, 2018

Contact

Consumers

Pfizer Consumer Healthcare Information Line
 1-800-88-Advil (1-800-882-3845)

Media

Jessica Smith
  Jessica.m.smith@pfizer.com
 212 733 6213

Announcement

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

Pfizer concluded that the use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose. The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness.

Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle temporarily reduces fever, relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.

Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018. (more…)

For Immediate Release

August 14, 2018

Contact

Consumers

Zakah Life LLC
 1-877-MY-ZAKAH

Media

Cole Stegman
 1-877-MY-ZAKAH

Announcement

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurisms), endocarditis, and arthritis.

The recalled Kratom products were distributed nationwide in retail stores and through mail orders.

The affected products, lot, best by dates and packaging are as follows:

Product Name Quantity and Dosage Form Packaging Lot #
Super Green Maeng Da Premium Kratom Powder 100 g 4 oz. black and clear organic rice paper bag containing 100g of kratom BSG010118
Powerful Red Vein Bali Premium Kratom Powder 100 g 4 oz. black and clear organic rice paper bag containing 100g of kratom BPR010118
Super Green Maeng Da Premium Kratom Capsules 90 capsules 275 cc plastic bottles SG050118
Powerful Red Vein Bali Premium Kratom Capsules 90 capsules 275 cc plastic bottles PR050118

No illnesses have been reported to date in connection with this problem. (more…)

For Immediate Release

August 13, 2018

Contact

Consumers

World Organix LLC
  fdarecall@blissfulremedies.com
 1-800-435-8533

Announcement

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls. (more…)

For Immediate Release

July 25, 2018

Contact

Consumers

AMPI Response Center
 734-773-4220

Media

Sarah Schmidt
 507-354-8295, extension 3665

Announcement

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The products included in the recall can be identified by the following lot numbers, which can be found printed along the top of the bag. Images of the bags can be found below.

  • 7000.118.121.BL – 7000.118.125.BL
  • 7000.118.144.BL – 7000.118.149.BL
  • 7000.118.153.BL – 7000.118.156.BL
  • 7000.118.158.BL – 7000.118.165.BL

AMPI dry whey powder is not sold directly to consumers, but is used as an ingredient in a number of foods. It is sold directly to manufacturers and also distributed by brokers. A limited amount was sold for animal feed. All products shipped into the marketplace tested negative for salmonella as part of AMPI’s routine testing program. However, because additional product tested positive for salmonella under AMPI’s routine test and hold procedures, the company is recalling product as a precautionary measure. AMPI has ceased production at its Blair, Wis., dry whey plant, is currently investigating the cause for the positive samples, and will take all necessary remedial actions.

All customers that have received the dry whey powder lots have been notified by AMPI and instructed to return the recalled powder, or to document the destruction of the powder, after contacting AMPI for specific instructions. (more…)

For Immediate Release

July 6, 2018

Contact

Consumers

Customer Experience
  hello@saje.com
 1-877-275-7253

Media

Trevor Ellestad
  tellestad@saje.com
 (604) 561-8356

Announcement

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosais an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

The product being recalled is:

Brand Name & Product Name Product SKU Package Size Lot Number Expiry Date
Saje Natural Wellness Splish Splash Gentle Baby Wash 700552
(USA/Int’l)
8.5 fl. oz. 814020 All expiry dates
Saje Natural Wellness Splish Splash Gentle Baby Wash (found in Wee and Well Gentle Baby Care Kit) 700561
(USA/Int’l)
1.7 fl. oz. 814020 All expiry dates

The product is distributed in the United States through Saje retail locations in California, New Jersey, and New York. The product is also distributed through online sales across the United States and internationally.

Based on routine sample testing, one lot (814020) of Splish Splash Gentle Baby Wash 8.5 fl. oz. was found to contain the bacteria Pseudomonas aeruginosa.

There have not been any reported adverse reactions for this product in the United States to date. (more…)

For Immediate Release

July 6, 2018

Contact

Consumers

 1-800-257-3315

Announcement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

Prescript-Assist dietary supplement was distributed nationwide, including through online sales on the LL’s Magnetic Clay website and brick and mortar retailers. The Prescript-Assist product is available through distributors other than LL’s Magnetic Clay that purchased the product from the same source.

All lots sold between 1/29/2015 – 12/31/2017 are potentially impacted. The white bottles contain capsules in quantities of either 60 or 90 capsules per bottle. A representative label is included below.

No illnesses regarding these products have been reported to date. (more…)

For Immediate Release

June 30, 2018

Contact

Consumers

Customer Support
 fdarecall@blissfulremedies.com
 1-800-435-8533

Announcement

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

These products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infect ion with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product is used as Nevada and is packaged in white foil pouches with Lot No.: 112710 and expiration 03/2019 . The affected products are as follows:

Products Label Size Packaging
Red Maeng Da (100% Mitragyna
Speciosa)
50 capsules White Foil Pouches
Gold Series Ultra Enhanced Indo
(100% Mitragyna Speciosa)
50 capsules White Foil Pouches
Kratom+CBD., CBD infused
Maeng Da
50 capsules White Foil Pouches

These products were distributed to retail stores located in AK, AZ, CA, FL, GA, HI, IL, KS, KY, CT, MA, MI, MN, MO, MS, NE, NJ, NM, NY, OH, OK, PA, PR, SD, TX, VA.

Blissful Remedies is notifying its retailers by e-mail and/or telephone and customers are urged to return the recalled products to us or immediately discard them for credit.

Consumers with questions regarding this recall can contact the company at fdarecall@blissfulremedies.com or 1-800-435-8533 , 9 am to 6 pm (Central Time Zone), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with 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. (more…)