Staska Pharmaceuticals is recalling one lot, SP2400058, of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500 mg/mL, 50 mL vials due to the presence of glass particulates.
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.
To date, Staska Pharmaceuticals has not received any reports of the presence of particulate matter, nor any adverse events related to this recall.
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