Category: Health, Beauty, Wellness

Summary

Company Announcement Date:
March 11, 2019
FDA Publish Date:
May 20, 2019
Reason for Announcement:
Company Name:
Claire’s Stores
Brand Name:
Claire’s
Product Description:
Makeup

Company Announcement

Out of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

The products are no longer available in our stores, but may still be in the homes of consumers. The SKUs/Lots being recalled are:

  • Claire’s Eyeshadows, UPC #888711847165, SKU #84716, Lot No. 08/17
  • Claire’s Compact Powder, UPC #888711839153, SKU #83915, Lot No. 07/15
  • Claire’s Contour Palette, UPC #888711401947, SKU #40194, Lot No. 04/17

The SKUs and UPCs can be found on the price tickets affixed to the products, and all batch numbers are shown on the back panels below the ingredient lists.

All three products were offered for sale between October 2016 and March 2019 and have been removed from the marketplace. They were sold in Claire’s stores nationwide and on www.claires.com. External Link DisclaimerAny consumers who have purchased these products should discontinue use and return them to a Claire’s store for a full refund.

To date, Claire’s is not aware of any adverse reactions, injuries or illness caused by the possible presence of asbestos in the recalled products. Claire’s continues to have confidence in the safety and composition of its products and is taking these actions out of an abundance of caution. We are working with FDA to ensure the agency and our customers share that confidence. (more…)

Summary

Company Announcement Date:
March 01, 2019
FDA Publish Date:
May 09, 2019
Product Type:
Dietary Supplements
Nutritional Supplement
Reason for Announcement:
Company Name:
Sunstone Organics
Brand Name:
Sunstone Organics
Product Description:
White Vein Kratom and Maeng Da Kratom

Company Announcement

Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Risk Statement: The product potentially could result in contracting salmonella. Symptoms of salmonella can include illness, vomiting, and some cases even death. This risk is higher for users a compromised or weak immune system, including elderly and young children. Sunstone Organics has not received any reports of adverse events to date related to this recall. (more…)

Summary

Company Announcement Date:
February 28, 2019
FDA Publish Date:
March 06, 2019
Product Type:
Food & Beverages
Meal Replacements
Reason for Announcement:
Company Name:
Sunstone Organics
Brand Name:
Sunstone Organics
Product Description:
White Vein Kratom and Maeng Da Kratom

Company Announcement

Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Risk Statement: The product potentially could result in contracting salmonella. Symptoms of salmonella can include illness, vomiting, and some cases even death. This risk is higher for users a compromised or weak immune system, including elderly and young children. Sunstone Organics has not received any reports of adverse events to date related to this recall. (more…)

Summary

Company Announcement Date:
February 25, 2019
FDA Publish Date:
February 27, 2019
Product Type:
Dietary Supplements
Drugs
Reason for Announcement:
Company Name:
Golean Detox USA
Brand Name:
Golean Detox
Product Description:
Dietary Supplement for Weight Loss

Company Announcement

Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Products containing sibutramine pose 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. Health risks of ingesting phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, Golean Detox USA  has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
February 08, 2019
FDA Publish Date:
May 20, 2019
Product Type:
Drugs
Reason for Announcement:
Company Name:
McDaniel Life-Line LLC
Brand Name:
McDaniel Life-Line
Product Description:
Indian Herb (topical)

Company Announcement

Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body.  Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

Use of the product could result in temporary or permanent damage or loss of body function or structure.  To date, McDaniel Life-Line LLC has received a report of one adverse injury. (more…)

Summary

Company Announcement Date:
January 08, 2019
FDA Publish Date:
May 20, 2019
Reason for Announcement:
Company Name:
Happy Together, Inc.
Brand Name:
Rhino
Product Description:
Rhino 5K capsules

Company Announcement

Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. To date, Happy Together Inc. has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
December 11, 2018
FDA Publish Date:
April 11, 2019
Product Type:
Medical Devices
Obstetrical & Gynecological
Reason for Announcement:
Product Safety, Potential Packaging Issue, Damage
Company Name:
Kimberly-Clark
Brand Name:
Kotex
Product Description:
Tampons

Company Announcement

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

The recall is limited to specific lots of U by Kotex® Sleek® Tampons, Regular Absorbency, that were manufactured between October 7, 2016 and October 16, 2018 and distributed between October 17, 2016 and October 23, 2018. Consumers can identify this product by looking for specific lot numbers found on the bottom of the package. A full list of recalled lot numbers is available on the U by KotexExternal Link Disclaimer®External Link Disclaimer website. Retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores.

No other U by Kotex-branded products are subject to this recall.

Kimberly-Clark has received reports from consumers of the U by Kotex® Sleek® Tampons, Regular Absorbency, unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.

(more…)

Summary

Company Announcement Date:
December 05, 2018
FDA Publish Date:
March 18, 2019
Product Type:
Drugs
Over-the-Counter Drugs
Reason for Announcement:
Device & Drug Safety, Ingredient Level
Company Name:
Tris Pharma
Brand Name:
Family Wellness, CVS, Equate
Product Description:
Infants’ Ibuprofen

Company Announcement

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall. (more…)

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…)