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Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance, USA

3 weeks ago •source www.fda.gov

Recall notice

Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance photo #1

United States

Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good manufacturing practice (cGMP) requirements. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.

Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024

Source: www.fda.gov

#drugs #recall #us

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Aruba Aloe Hand Sanitizer Gel and Alcoholada Gel - recalled because they contain Methanol, USA

3 weeks ago •source www.fda.gov

Recall notice

Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to contain alcohol denatured with methanol. Products were distributed between 5/1/2021 and 10/27/2023 and sold in … See More
the US online only via the Aruba Aloe Balm N.V. website. To date, Aruba Aloe Balm N.V. has not received any reports of adverse events related to these products.

Aruba Aloe Hand Sanitizer Gel is used as a sanitizer to help reduce bacteria that potentially can cause disease and is packaged in 12 fl oz (355 mL) dark green plastic bottles with white label reading in part “ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe”, with barcode 0 82252 03300 5.

Aruba Aloe Alcoholada Gel is used for temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations and is packaged in two sizes: 2.2 fl oz (65 mL) plastic bottles with barcode 0 82252 34030 1 and 8.5 fl oz (251 mL) plastic bottles with barcode 0 82252 03120 9. The plastic bottles are transparent with a label reading in part “Alcoholada Gel Pain Relieving Gel 0.5% Lidocaine Hydrochloride”.

The affected Aruba Aloe Hand Sanitizer GEL product lots (filled in 12, 2.2, and 8.5 fl. oz bottles bottles) can be viewed in the link below.

Aruba Aloe Balm N.V. has notified all customers that bought these products by email and has offered a discount coupon for a next purchase. Consumers that have products which are being recalled should stop using and discard the product.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

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: Aruba Aloe Balm N.V.
Brand name: Aruba Aloe
Product recalled: Hand Sanitizer Gel and Alcoholada Gel
Reason of the recall: Product contains methanol
FDA Recall date: April 05, 2024

Source: www.fda.gov
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#recall #us

Aruba Aloe Hand Sanitizer Gel and Alcoholada Gel - recalled because they contain Methanol photo #1
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