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Safety Report: WishGarden Herbs Remedies Cord Care and Goldenseal Powder - recalled due to potential Cronobacter sakazakii contamination, USA

3 years ago source fda.gov

Recall notice

United States

Company name: WishGarden Herbs, Inc.
Brand name: WishGarden Herbal Remedies
Product recalled: Cord Care and Goldenseal Powder
Reason of the recall: Product may be contaminated with Cronobacter sakazakii
FDA Recall date: December 04, 2020
Recall details: Company Announcement WishGarden Herbs, Inc. is voluntarily recalling, to the consumer level, 14 lots of Cord Care and Goldenseal Powder products produced after 7/26/18 with expiration dates between 7/26/18 and 9/1/20. After receiving notice of a supply chain issue, WishGarden has determined these products were manufactured using ingredients potentially contaminated with Cronobacter sakazakii bacteria. Use of these products, when contaminated with this bacteria, may cause serious infections with severe outcomes, including death, especially in vulnerable patients with compromised immune systems and infants. Catherine Hunziker, WishGarden President, stated, “As a leading herbal product company for more than 40 years, we take the safety of our products seriously and we feel it is important to recall this product out of an abundance of caution. Consumer safety is our highest priority.”

Cord Care Powder is marketed to dry umbilical cords and is applied externally to skin. It is packaged in 1oz containers and labeled with UPC 6-56490-24730-4. The affected product lots are P227-P235. The lot and expiration date can be found below the label barcode. Goldenseal Powder is marketed as a drying powder applied externally to skin. It is packaged in 1oz containers and labeled with UPC 6-56490-64137-9. Affected product lots are P116-P120. The lot and expiration date can be found below the label barcode. These products were distributed nationwide in the USA through select practitioners.

WishGarden Herbs has notified its distributors and customers by phone, mail and email. Consumers who have purchased this recalled product should discontinue use immediately and not open any sealed packages. The product should be mailed directly to WishGarden Herbs corporate headquarters at 321 South Taylor Ave. Suite 100 Louisville, CO 80027 for a full refund. Consumers with questions regarding this recall can contact WishGarden Herbs by calling the company’s recall hotline at 720-889-9878 (M-F, 9am - 5pm MST) or Email: recall@wishgardenherbs.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wishgarden-herbs-issues-voluntary-nationwide-recall-cord-care-and-goldenseal-powder-due-bacterial

Source: FDA

#drugs #unitedstates

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