Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles

Summary

Company Announcement

FOR IMMEDIATE RELEASE – 10/10/2024 – Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 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 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. This risk is further reduced as the product label contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering.

The Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL 50mL 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.

STASKA PHARMACEUTICALS places the utmost emphasis on patient safety and product quality. STASKA has directly notified all customers who received the product by electronic mail and telephone and has arranged for the return and replacement of all recalled products. Healthcare providers that have the product lot which is being recalled should stop using, quarantine, and contact STASKA PHARMACEUTICALS directly to arrange for return and replacement.

Consumers with questions regarding this recall can contact STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370 Monday through Friday 8 AM to 5 PM 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.