FDA MedWatch – Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500 mg/mL by Staska Pharmaceuticals

TOPIC: FDA MedWatch – Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500 mg/mL by Staska Pharmaceuticals: Recall – Due to the Presence of Glass Particles

AUDIENCE: Health Professional, Patient 

ISSUE: 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.

For more information about this recall, click on the red button Read Recall below.

BACKGROUND: Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500 mg/mL, 50 mL is used as a vitamin supplement.  

RECOMMENDATIONS: 

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Health care 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.
• Patients 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. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.  

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