BENNET, NEBRASKA — A number of 500mg/mL vials Ascorbic Acid Solution for Injection, produced by Staska Pharmaceuticals and marked “Preservative Free” and “Non-Corn,” were recalled to the user level last Thursday, October 11.
Officials took action after glass particulates were discovered in a single production lot of vials. In the event that the injectable product containing particulate matter is administered, a patient may experience localized irritation or swelling. In more serious cases, the matter could cause blockages in blood vessels within the heart, lungs, or brain, putting a patient at risk for stroke, or even death. A variety of factors may impact how often the events occur, and how severe: “the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.”
As of the time of the FDA announcement, Staska Pharmaceuticals has not been alerted to any consumer reports of particulate matter being discovered in the product, and no adverse experiences have been reported. Officials noted that risks should be mitigated by a statement on the product label that directs instructs medical professionals to inspect the product for any foreign matter before use.
Indicated to be used as a vitamin supplement, Ascorbic Acid Solution for Injection (Preservation Free, Non-Corn) 500mg/mL comes in amber-colored vials. Licensed medical providers across the country received the affected lot (SP2400058) from July 31, 2024, to August 27, 2024. Products under the lot number bear an expiration date of 12/31/2024.
Since the problem was discovered, all relevant Staska customers have been notified of the recall by email and telephone, and a return and replacement program has been established directly by the company. All affected products should no longer be used and should be kept in quarantine until it is ready to be returned or replaced.
Staska Pharmaceuticals can be reached Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Time by calling 402-782-2207 or 888-801-1370. Anyone who may have experienced issues believed to be linked to use of the drug product is advised to consult their medical provider.
As the FDA continues to monitor this recall, consumers are encouraged to report any relevant adverse events or problems to the agency’s MedWatch Adverse Event Reporting program. Instructions to do so are listed in the FDA announcement.
If you or a loved one has suffered an adverse health outcome that can be traced to the use of a contaminated or compromised injectable product, you could be owed significant compensation. Reach out to Oliver Law Office at 614-220-9100 or via our contact form to book a free, no-risk case review. Our seasoned team of medical device lawyers is prepared to learn about your case and help you navigate the next steps.
