WASHINGTON, D.C. — The U.S. Food and Drug Administration announced that STASKA PHARMACEUTICALS, INC., based in Bennet, NE, has initiated a voluntary recall of one lot of its Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials. This recall affects products distributed nationwide to licensed healthcare providers between July 31, 2024, and August 27, 2024, due to the detection of glass particulates in the vials used for production.
The presence of glass particles in an injectable solution poses significant health risks, including local irritation or swelling and potentially severe complications such as blockages in the heart, lungs, or brain, which could lead to stroke or fatal outcomes. Such adverse events could vary in frequency and severity based on factors like particle size, quantity, and patient health conditions.
STASKA PHARMACEUTICALS has reported no adverse events or complaints about particulate matter thus far. The company emphasizes that the product label instructs healthcare professionals to conduct a visual inspection for foreign particulates before administration, thereby mitigating risks.
The affected lot is identified as SP2400058 with an expiration date of December 31, 2024. STASKA PHARMACEUTICALS has directly reached out to all customers who received the affected lot via email and phone, arranging for the return and replacement of the recalled products. Healthcare providers in possession of this lot are advised to cease usage, quarantine the products, and contact STASKA PHARMACEUTICALS for return and replacement procedures.
Consumers with inquiries concerning this recall can reach STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370, available Monday through Friday from 8 AM to 5 PM CDT. Individuals who have encountered issues potentially related to the use of this drug should consult their healthcare provider promptly.
Furthermore, any adverse reactions or quality issues linked to this product can be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, via regular mail, or by fax. To submit by mail or fax, individuals can download the form or request it by calling 1-800-332-1088, and then return the completed form to the designated address or fax it to 1-800-FDA-0178..
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