Staska Pharmaceuticals, Inc. is voluntarily recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence
of glass particulates in one lot of vials used in the production of this batch.
The Ascorbic Acid Solution for Injection is used as a vitamin supplement and is packaged in amber colored vials and the affected lot is SP2400058 with an expiration date of 12/31/2024. The product was distributed nationwide to licensed healthcare providers between 07/31/2024 and 08/27/2024.
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.
Consumers with questions regarding this recall can contact STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370, Monday through Friday, 8am-5pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Source: FDA
