Vitamin C Recalled Nationally at the Highest Risk Level

Vitamin C is one of the most common nutrition supplements in the US, especially during cold and flu season. Aside from boosting the immune system, vitamin C can also improve the health of your heart, bones, skin, and more.

Even before intravenous infusions became a popular method for some Americans to get their vitamins, doctors were prescribing ascorbic acid injections to treat severe vitamin C deficiencies in patients who cannot take oral supplements. For those patients, a recent recall set off warnings which are now more concerning after an update this week.

On October 16, the U.S. Food and Drug Administration (FDA) announced that STASKA Pharmaceuticals, Inc., a Nebraska-based company, had initiated a recall on one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL due to the presence of glass particulate matter. (Though neither the company nor the FDA had initially specified how many individual units were in the affected lot, the updated announcement notes that 4,773 vials of the solution were affected by the recall.)

Now, on November 7, an updated notice says they have categorized the recall’s risk level as “Class I.” This is the FDA’s highest possible risk classification, indicating “a reasonable probability that a product could cause serious injury or death.”

The FDA notes that some people may experience only temporary side effects from using the contaminated products. For instance, “local irritation or swelling” are considered common after injecting a product containing particulate matter, the FDA says.

However, they advise that the consequences in this case could be more serious. “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 FDA wrote in its initial notice. “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,” they wrote.

No adverse effects were reported at the time of the initial recall, and the update does not say whether any adverse effects have been reported in the time since. The FDA notes that the product label “contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering,” a failsafe that reduces the likelihood that the contaminated products will be used on patients.

The supplements were packaged in amber-colored vials, and were distributed to healthcare providers between July 31, 2024 and August 27, 2024. The lot number associated with the contaminated products is SP2400058, and the expiration date is listed as December 31, 2024.

If you have the recalled vials in your possession, stop using them, quarantine, and contact STASKA Pharmaceuticals directly to arrange for a return and replacement. Consumers and healthcare providers who have questions about the recall can contact STASKA Pharmaceuticals by phone at (402) 782-2207 or (888) 801-1370 (Monday through Friday 8 am to 5 pm CDT).

If you’re concerned about adverse effects related to the recall, the FDA recommends contacting your doctor or healthcare provider for medical assistance. Patients are also encouraged to report their adverse effects to the FDA via the MedWatch Adverse Event Reporting.

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