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USA
Company name: WishGarden Herbs
Brand name: WishGarden Herbal Remedies
Product recalled: Happy Ducts Compress
Reason of the recall: Product may be contaminated with Cronobacter sakazakii.
FDA Recall date: December 01, 2020
Recall details: WishGarden Herbs, Inc. is voluntarily recalling one lot of Happy Ducts Compress to the consumer level. After becoming aware of a possible supply chain contamination, a retained product was found to contain the Cronobacter sakazakii bacteria. WishGarden has initiated this recall due to the possible bacterial contamination of Happy Ducts Compress products of lot 53664.

WishGarden Herbs has reported that no medical illnesses or harmful effects have resulted from the recalled products thus far. To date 36 of 46 units in distribution have been accounted for. Happy Ducts Compress, when contaminated with Cronobacter sakazakii and applied to breast tissue of nursing women, may result in serious and sometimes life-threatening infections of nursing infants. Infants can be exposed while nursing through residual bacteria on their mother’s skin.

Additionally, topical application of Happy Ducts Compress contaminated with Cronobacter sakazakii may cause soft tissue infections in nursing women when applied to broken skin such as cracked nipples. 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.”

Happy Ducts Compress is used by nursing women as an external compress applied to breast tissue. It is packaged in 3 oz containers and labelled with UPC 6-56490-20223-5. The affected Happy Ducts Compress affected lot is 53664, Exp 08/2022. The lot and expiration date can be found above the label barcode. This product was distributed through select practitioners and online retailers.

WishGarden Herbs is notifying its distributors and customers by phone and email. Consumers who have purchased this product through their practitioner or retail site should not open the package or should discontinue use immediately. Instead, they should dispose of the product or mail it 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 fda.gov

Source: FDA