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The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US FDA about voluntary recall of some lots of Happy Ducts Compress, Cord Care and Goldenseal Powder by WishGarden Herbs. The recall is due to a possible supply chain contamination with the bacteria Cronobacter sakazakii.
Happy Ducts Compress, used by nursing women when contaminated with Cronobacter sakazakii and applied to breast tissue poses dual risks. It may cause serious infections of nursing infants and could be potentially life-threatening to them. Furthermore, applying Happy Ducts Compress contaminated with Cronobacter sakazakii to broken skin such as cracked nipples may result in soft tissue infections in nursing mothers.
Cord Care is a herbal powder applied externally to the skin to dry and disinfect the umbilical cord of new-borns. Goldenseal is also a homeopathic powder applied externally to skin that works by drying the umbilical cord. Use of these powders, when contaminated with Cronobacter sakazakii may cause serious infections with severe outcomes, including death, particularly in infants and immunocompromised patients.
Affected product details
Product 1 | Product 2 | Product 3 | |
Product name | Cord Care Powder | Goldenseal Powder | Happy Ducts Compress |
Affected Lots | P227-P235 | P116-P120 | 53664 |
Manufacturer | WishGarden Herbs | WishGarden Herbs | WishGarden Herbs |
Healthcare professionals and patients in possession of these lots of Happy Ducts Compress, Cord Care and Goldenseal Powder being recalled should stop use and further distribution, and submit the product to the nearest NAFDAC office.
Healthcare professionals are encouraged to report any adverse events or side effects related to the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), the MedSafety App or via pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management