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

3 years ago

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 fda.gov

Source: FDA

303


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Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
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- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
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Source: fda.gov
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Source: fda.gov
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Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

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