Glass Particles Prompt Class I Recall for Injection

Staska Pharmaceuticals Inc. is recalling 4773 vials of ascorbic acid solution for injection for containing glass particulate matter, according to the November 13, 2024, US Food and Drug Administration (FDA) Enforcement Report. The FDA designated the recall Class I, which warns use of the affected product could cause serious adverse health consequences or death.

“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,” Staska Pharmaceuticals stated in an October 10, 2024, announcement. “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.”

The recall affects ascorbic acid solution for injection (preservative free, non-corn), 500 mg/mL, in 50-mL single-use vials, from lot SP2400058 (Exp. 12/31/24). The vials were distributed to licensed health care providers throughout the United States between July 31, 2024, and August 27, 2024.

Staska Pharmaceuticals voluntarily initiated the recall September 30, 2024. On November 7, 2024, the FDA issued its Class I designation. 

At the time of the company announcement, Staska Pharmaceuticals had not received any reports of adverse events related to the recall. 

Ascorbic acid solution for injection (preservative free, non-corn) is a vitamin supplement packaged in amber-colored vials.