- Company Announcement Date:
- February 01, 2023
- FDA Publish Date:
- February 01, 2023
- Product Type:
Food & Beverages
Skin Care Products
- Reason for Announcement:
Recall Reason Description
May contain lead
- Company Name:
- Shop Me Ca
- Brand Name:
- Product Description:
Baby Skin Cream
Shop Me Ca of Herndon, VA is recalling its 10-gram tubes of “Diep Bao Cream” because they have the potential to be contaminated with lead. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems.
Diep Bao Cream was sold nationwide through Shop Me Ca’s Facebook page and a Vietnamese Moms’ Facebook groups: Hội Mẹ Việt Nuôi con Tại Mỹ, Mẹ Việt Tại Mỹ, Chuyên Đồ Bầu và Chăm Sóc Sau Sinh, and Nguyễn Ngọc. These Facebook groups are not associated with Shop Me Ca.
The product is packaged in an outer cardboard white box with a 10-gram white plastic tube inside. All labeling is in Vietnamese. The bottom side panel of the cardboard box is marked with NSX 05/01/2021 HSD 05/07/2023.
The recall was initiated after testing by Oregon Health Authority (OHA) found high levels of lead in two samples of the product. As a result of using Diep Bao Cream, two infants were found to have elevated blood lead levels. One case was identified after an initial post on a Vietnamese moms’ Facebook group page in December 2022 to alert customers about the product. The second case was reported by the Oregon Health Authority in January 2023. Shop Me Ca initially posted on their Facebook page in December 2022, that the products tested positive for lead. Shop Me Ca is voluntarily recalling the product.
The sale of the product has been suspended while FDA, OHA, and the company continue to investigate the source of the problem.
Customers who have purchased 10-gram tubes of “Diep Bao Cream” should immediately discontinue use of the product and dispose of it immediately. Consumers with questions may contact the company at [email protected] Monday through Friday from 9AM to 5PM EST.
Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol sunscreen products.
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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
See Vietnamese Translation attached.
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