As the season for colds, flu, and COVID-19 approaches, many individuals are reaching for vitamin C supplements to enhance their immune health. However, on October 16, 2024, the US Food and Drug Administration (FDA) made a startling announcement. A specific type of ascorbic acid, widely sold across the country, has been voluntarily recalled due to the presence of glass particles.
STASKA Pharmaceuticals, Inc., a company based in Nebraska, has reported that one batch of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL is affected by the recall. Details on the exact number of affected units have not been disclosed by either the company or the FDA.
The recalled lot, identified by number SP2400058, is set to expire on December 31, 2024. Packaged in amber-colored vials, these products were distributed to healthcare providers between July 31 and August 27, 2024. The recall is being conducted “to the user level.”
Ascorbic acid injections are primarily prescribed for patients suffering from severe vitamin C deficiencies or scurvy, particularly in cases where oral supplements are not viable. According to the Cleveland Clinic, about 7.1% of the U.S. population is vitamin C deficient, although scurvy itself is rare due to adequate dietary intake among most Americans.
While the FDA has not yet assigned a classification to the recall—which would clarify the potential health risks—they advise that using a contaminated product could lead to severe health concerns.
The recall notice highlights that local irritation or swelling may occur if the injectable solution contains foreign particles. In more severe instances, glass particles could obstruct blood vessels in vital organs such as the heart, lungs, or brain, potentially leading to a stroke or even death, as indicated by the FDA. The severity of these reactions can vary based on factors such as particle size and quantity, existing health conditions, and vascular irregularities.
No adverse effects related to the recall have been reported so far. The FDA has instructed healthcare providers who have the recalled vials to cease their use immediately, quarantine the products, and reach out to STASKA Pharmaceuticals for return and replacement procedures. The rationale for the FDA’s recommendation of “quarantine” has not been clearly explained.
If consumers have concerns about the recall, they are encouraged to contact STASKA Pharmaceuticals at either (402) 782-2207 or (888) 801-1370 during business hours (Monday through Friday, 8 am to 5 pm CDT).
For anyone who believes they may be experiencing adverse effects due to the recalled products, the FDA strongly recommends contacting a healthcare professional. Patients should also report any adverse effects to the FDA via the MedWatch Adverse Event Reporting system.
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