Safety Report: Staska Pharmaceuticals Ascorbic Acid Solution - recalled due to glass particulates, USA

United States

Staska Pharmaceuticals, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch. The product was distributed nationwide in USA to licensed healthcare providers between 07/31/2024 and 08/27/2024.

The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.

This risk is further reduced as the product label contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering.

The Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL 50mL 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.

All customers who received the product should return and replace of all recalled products. Healthcare providers that have the product lot which is being recalled should stop using.

In case you experienced harm from extraneous materials, 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: STASKA Pharmaceuticals Inc.
Brand name: STASKA Pharmaceuticals
Product recalled: Ascorbic Acid Solution for Injection
Reason of the recall: Device & Drug Safety – Presence of glass particulates
FDA Recall date: October 16, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection