Teva Pharmaceuticals Injection USP - recalled due to particulate matter, USA

2 years ago •source www.fda.gov

Recall notice

Teva Pharmaceuticals Injection USP - recalled due to particulate matter photo #1

United States

Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. No other vials have been observed to contain this defect.

To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot.

The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.

Information about the affected product is listed in below. It is packed in 5 mL Single Dose Vials. Teva distributed 1,565 vials Nationwide from 12-04-2020 through 08-18-2021 to 4 of its Wholesale customers under the label for Teva Pharmaceuticals USA, Inc.

- Recalled product:

Vial/Carton NDC: 0703-4154-11
Lot # 31329657B
Exp. Date 08/2023

Any consumer who has questions or concerns should first consult with their health care provider(s). This recall was made with the knowledge of the Food and Drug Administration.

Company name: Teva Pharmaceuticals
Brand name: Teva Pharmaceuticals
Product recalled: IDArubicin Hydrochloride Injection USP
Reason of the recall: Potential Particulate Matter (silica and iron oxide)
FDA Recall date: March 29, 2022

Source: www.fda.gov

#drugs #blood #us #sub

303

Recent Interesting Reports

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

1 week ago •source www.fda.gov

Recall notice

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 … See More
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
See Less

#recall #drugs #us

Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance photo #1
303
R

I received an order Verti Bioribose and I didn't order this, Parker, Colorado, USA

3 weeks ago •reported by user-rcfzp646

The package came as fulfillment House PO Box 5708 from Tampa, FL 33675-5708
with the bottle inside1.0 oz
I have never ordered this and want to know how they git my address and name. What is my next steps ? How do I get the charges refunded? … See More
This harassment should not be allowed to happen!!
How do I found out where they got my name and if they scammed a credit card!!! This isn't the first time I was sent something I didn't order. How Do I return it and not on my dime, please.
See Less

#unorderedpackage #delivery #parker #colorado #us

I received an order Verti Bioribose and I didn't order this photo #1
23

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