Last Updated on October 15, 2024 by The Health Master
Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials.
Microscopic and elemental analyses determined the presence of particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling or infection 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.
To date, no adverse event reports have been received for these recalled lots, which were produced and sold in 2020 and 2021.
Sodium Acetate Injection, USP is indicated as a source of sodium, for addition to large volume IV fluids to prevent or correct low blood sodium levels in patients with restricted or no oral intake.
It is also useful as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.
Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lots, and to return the product to Fresenius Kabi.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Drug recall: Macleods recalls products for these manufacturing issues
Drug recall: Aurobindo, Sun Pharma recall these products
Drug recall: Medical Device – Infusion Pumps recalled due to this reason
Drug recall: Red Mammoth capsules recalled due to this reason
Drug recall: Red Pill Capsules recalled due to this reason
Drug recall: Blaine Labs recalled of RevitaDerm Wound Care Gel Due to this reason
USFDA gives tentative nod to Alembic for Macitentan Tablets 10 mg
Govt releases draft National Medical Device Policy 2022
Deadline extended for proposals under PLI scheme for Bulk Drugs
USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets
Orders to close these 5 Pharmaceutical units
USFDA inspections back in full swing for Pharma Companies
Drug recall: Macleods recalls products for these manufacturing issues
NITI Aayog to expand ‘Medicines from the Sky’ project
Make Pharma Companies liable for bribing doctors: PIL
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
