Vitamin C is one of the most widely used nutritional supplements in the U.S., particularly during cold and flu season. Beyond enhancing immune function, vitamin C contributes to better heart, bone, and skin health, among other benefits.
Historically, before intravenous infusions became a common practice for vitamin intake, healthcare professionals would prescribe ascorbic acid injections to address severe vitamin C deficiencies in patients unable to take oral supplements. A recent recall regarding one such product has raised concerns, particularly following an update this week.
On October 16, the U.S. Food and Drug Administration (FDA) announced that STASKA Pharmaceuticals, Inc., based in Nebraska, had voluntarily recalled a single lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL, due to the discovery of glass particles in the solution. Although the initial announcement did not specify the number of affected units, the updated information reveals that 4,773 vials are involved in this recall.
As of November 7, an updated notice has classified the recall’s risk level as “Class I”, the highest level of risk defined by the FDA. This classification suggests a reasonable likelihood that the product could cause serious injury or even death.
The FDA indicates that some users may only experience mild temporary side effects, such as “local irritation or swelling” after injecting a product with particulate matter. However, the potential health consequences could be far more serious. “The particulate matter could travel through and block blood vessels in the heart, lungs, or brain, potentially leading to stroke or death,” the FDA warned in the initial recall notice. The severity and frequency of these adverse effects could depend on several factors including the size and amount of particles present, the overall health of the patient, and any existing vascular issues.
At the time of the first recall announcement, no adverse reactions had been reported. The updated information does not clarify whether any adverse effects have emerged since then. The FDA has stated that the product’s labeling instructs healthcare providers to visually inspect the vial for any foreign particles or precipitate prior to administration, a precaution aimed at preventing contaminated products from being used on patients.
The recalled solution came in amber-colored vials and was distributed to healthcare providers between July 31, 2024, and August 27, 2024. The associated lot number for the compromised products is SP2400058, and the expiration date is December 31, 2024.
If you possess any of the recalled vials, please cease using them immediately, quarantine the product, and reach out directly to STASKA Pharmaceuticals to arrange a return or replacement. For any inquiries regarding the recall, consumers and healthcare professionals can contact STASKA Pharmaceuticals at (402) 782-2207 or (888) 801-1370 (Monday through Friday, 8 a.m. to 5 p.m. CDT).
If you have health concerns related to this recall, the FDA recommends consulting your doctor or healthcare provider for advice. Patients are also encouraged to report any adverse effects to the FDA using the MedWatch Adverse Event Reporting system.
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