WASHINGTON (dpa-AFX) - Staska Pharmaceuticals, Inc. is recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level, according to the U.S. Food and Drug Administration. The recall was due to the presence of glass particulates in one lot of vials used in the production of the impacted batch.
The Ascorbic Acid Solution for Injection is used as a vitamin supplement and is packaged in amber colored vials and the affected lot is SP2400058 with an expiration date of 12/31/2024.
The impacted product was distributed across the country to licensed healthcare providers between 07/31/2024 and 08/27/2024.
According to the agency, administration of an injectable product that contains particulate matter may result in serious adverse events, including inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events, and even lead to death.
However, Staska has not received any reports of the presence of particulate matter, nor any adverse events related to the recall so far. The product label also contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering.
Staska has directly notified all customers who received the product and has arranged for the return and replacement of all recalled products.
In similar recalls, Sagent Pharmaceuticals in May called back two lots of chemotherapy drug Docetaxel Injection, USP due to potential presence of particulate matter from the stopper in the drug.
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