Category: Health, Beauty, Wellness

For Immediate Release

November 26, 2018

Contact

Consumers

Pfizer Consumer Healthcare Information Line
  1-800-323-3383

Media

Jessica Smith
  Jessica.m.smith@pfizer.com
 (212)733-6213

Announcement

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

The use of a leaking/damaged heat cell wrap could cause skin injuries such as burns/blisters and/or skin irritation on the wrap applied area. The product label warns not to use the product if heat cell contents leak and/or the wrap is damaged or torn.

ThermaCare® Muscle Pain Therapy provides heat therapy for temporary relief of minor muscular aches and pains associated with overexertion, strains, sprains, and arthritis. ThermaCare® Menstrual Pain Therapy provides heat therapy for temporary relief of minor menstrual cramp pain and associated backaches.

The ThermaCare® HeatWrap lots impacted are S68516 (Muscle Pain Therapy 3+1 count carton), T26686 (Muscle Pain Therapy 3 count carton), T26691 (Menstrual Pain Therapy 3 count carton), T26693 (Menstrual Pain Therapy 3+1 count carton); and 8054HA and 8054HB (11 count bundled packages contain one (1) package of Muscle Therapy Heatwraps, 8HR (3 Count) and two (2) packages of Joint Therapy Heatwraps, 8HR (4 Count)). Please note ThermaCare® Joint Therapy Heatwraps, 8HR are not subject to this recall notification.

These lots were distributed nationwide to retailers, wholesalers and distributors in the United States, Puerto Rico and the U.S. Virgin Islands from September 2017 through August 2018.

ThermaCare® HeatWrap Lot and Packaging Information

Product Name Lot Number Expiry Date SKU UPC Configuration/Count
Muscle Pain Therapy 8HR S68516 2020-07 F00573301314 305733013144 3 + 1 one-time use wraps per carton
Muscle Pain Therapy 8HR T26686 2020-07 F00573301303C 305733013038 3 one-time use wraps per carton
Menstrual Pain Therapy 8HR T26691 2020-07 F0057332002H 305733020029 3 one-time use wraps per carton
Menstrual Pain Therapy 8HR T26693 2020-08 F00573302044 305733020449 3 + 1 one-time use wraps per carton

Bundled Lots

Product Name Bundled Lot Number Carton/ Pouch Lot Number Expiry Date SKU UPC Configuration/Count
Joint/Muscle Pain Therapy 8HR 8054HA T26686 2020-07 F00573301311 305733013113 Multi-pack 11 one- time use wraps per carton
Joint/Muscle Pain Therapy 8HR 8054HB T26686 2020-07 F00573301311 305733013113 Multi-pack 11 one- time use wraps per carton

Pfizer Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. (more…)

For Immediate Release

November 7, 2018

Contact

Consumers

Recall Department
 contact@puriton.us

Announcement

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of the product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye which can lead to scarring, glaucoma or vision loss. To date, Kadesh, Inc. has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

October 15, 2018

Contact

Consumers

  usa@fatburnerszone.com
 (305) 741-2562

Media

Juan Avila
 (305) 741-2562

Announcement

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis  has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. To date, Fat Burners Zone has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

October 10, 2018

Contact

Consumers

Erin Sairafe
  recall@liveyon.com
 (800) 578-0983

Announcement

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions. (more…)

For Immediate Release

October 9, 2018

Contact

Consumers

  recall@sprayology.com
 240-224-7866

Media

Eleanor Whalen
  ewhalen@sprayology.com
 240-224-7866

Announcement

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

RISK STATEMENT-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.

Eight and Company LLC, d/b/a Sprayology has not to date received any reports of adverse events related to this recall. (more…)

For Immediate Release

September 20, 2018

Contact

Consumers

 214-221-1813

Announcement

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch,because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

MyoWhey was distributed through online mail orders to AR, TX, FL, MI, VA, and OK. MyoWhey was available through retail stores in TX, CA, OK, CO, and MO. MyoWhey was also available internationally in Chile and UAE.

MyoWhey Chocolate Cookie Crunch is sold in a white plastic container with a net weight of 5 pounds or 2.26 kg. Affected products can be identified by lot number PL: 0100518 Exp: 04/2020 which is printed on the bottom of the container.

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

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…)