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ManukaGuard Allercleanse Nasal Spray - recalled due to Yeast Contamination, USA

3 years ago

United States

Company name: NDAL MFG INC
Brand name: ManukaGuard
Product recalled: Allercleanse Nasal Spray
Reason of the recall: Due to Yeast Contamination
FDA Recall date: February 10, 2021
Recall details: NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse, nasal spray to the consumer level. The Allercleanse nasal sprays have been found to be contaminated with yeast.

Risk Statement:  The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or surgical intervention. However, use of this contaminated product in immunosuppressed individuals may result in life threatening invasive fungal infections.

NDAL MFG INC has not received any reports of adverse events related to this recall. The product is used as a NASAL SPRAY to clean nasal passages and sinuses of irritants and other environmental contaminants and is packaged in cardboard box with one nasal spray per box UPC 858631002128.  The affected Allercleanse lot is lot # 2010045 and BB 10/2023 expiration date.

Product was distributed Nationwide in the USA to 1 e-commerce website amazon.com, distributors and retail stores. NDAL MFG INC has notified its distributors and customers by e-mail followed by telephone and further email and has arranged for return/replacement etc. of all recalled products. 

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc., if they have not already done so. Consumers with questions regarding this recall can contact NDAL MFG INC by phone 1-800-916-1220 or e-mail address SUPPORT@MANUKAGUARD.COM, M-F 7:30 am to 4 pm PST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Check the full recall details on fda.gov

Source: FDA

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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.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- 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
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
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Source: fda.gov
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Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

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.

Source: recalls-rappels.canada.ca
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