FDA Recall of Homeopathic Oral Care Products - MedWaste Management FDA Recall of Homeopathic Oral Care Products - MedWaste Management

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FDA recall StellaLife Oral Rinse and advanced formula peppermint VEGA oral care rinse

FDA Recall of Homeopathic Oral Care Products

The FDA announced an immediate recall of two homeopathic oral care products this week. The products, manufactured by HomeoCare Laboratories, Inc. and sold under the brand name StellaLife® Inc., are contaminated with higher-than-acceptable levels of microbial content. The oral care spray and advanced oral rinse pose a risk to those with oral disease, compromised immune systems, or who are to undergo oral surgery. All consumers who utilize the products must be diligent in disposing of the recalled products if they are included in the recall.

As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.

SUMMARY

Date of Recall:

Announced: June 5, 2024

Public Notification: June 5, 2024

Name(s) of Drug:

StellaLife® VEGA Oral Care, Spray (Unflavored)

StellaLife® Advanced Formula Peppermint VEGA Oral Care Rinse

Company Name:

HomeoCare Laboratories, Inc.

Drug Indication:

Promotion of oral health

Oral hydration

Healthy gum support

FDA recall StellaLife Oral Rinse and advanced formula peppermint VEGA oral care rinse

Product Discription

StellaLife® oral care products are available online at the StellaLife® website and Amazon. The products are marketed as opioid-free solutions for dental concerns such as bad breath, canker sores, dry mouth, and more.

The products are packaged in white bottles with light blue, green, and white labels. Lot numbers and expiration dates are printed at the bottom left corner of the label.

Reason for Recall

An investigation noted higher-than-acceptable levels of bacterial loads within the products listed. While some of the bacteria aren’t typically dangerous, they may elicit dangerous health outcomes in those with compromised immune systems, dental disease, or who undergo surgery while using the product.

Impacts

Consumers who are immunocompromised, have dental disease or undergo surgery while using these products may be affected by the bacteria contained within. The bacteria may cause serious infections that, if left untreated, could become life-threatening.

Recall Lot Information

Consumers who utilize the listed products should compare their product’s label information with the information listed in the table below. If the numbers match, read further for instructions on participating in the recall.

Production DateRelease DateCustomersProduct NameNDCLot No.Expiration Date
02/16/202403/28/2024StellaLife Inc.StellaLife VEGA Oral Care, Spray Unflavored69685-121-01255202-2026
03/01/202403/28/2024StellaLife Inc.StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse69685-143-16255002-2026

FDA.gov

Have you found that your product is part of the recall? Here’s what you should do:

Consumers

If you find that your product is part of this recall, do the following:

  1. Stop using the product immediately.
  2. Notify your physician or dentist if you’ve utilized the product. Seek medical attention if you note any changes in your health.
  3. Consumers with questions can contact HomeoCare Inc. at (914) 920-5991. They are available from 9:00 a.m. to 3:00 p.m. EST Monday through Thursday. They are also available by email at qualityassurance@homeocare.com.
  4. If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

Retailers

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact HomeoCare Inc. at (914) 920-5991. They are available from 9:00 a.m. to 3:00 p.m. EST Monday through Thursday. They are also available by email at qualityassurance@homeocare.com.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact HomeoCare Inc. at (914) 920-5991. They are available from 9:00 a.m. to 3:00 p.m. EST Monday through Thursday. They are also available by email at qualityassurance@homeocare.com. Notify them of any recalled batches that have already been shipped to medical facilities.
  3. Notify affected medical facilities of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

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