FDA Recall of Vitamin C Supplement Containing Glass Fragments

This week, the FDA announced a concerning recall related to reports of glass fragments found in an injectable medication. The Ascorbic Acid solution is used to supplement a vitamin C deficiency and is administered by medical professionals. All medical professionals, as well as patients, should check vials to ensure that they do not administer or receive medications included in the recall. Administration of the recalled solution can lead to serious adverse events, including death.

As of the writing of this notice, the drug’s manufacturer has not announced any reports of adverse events related to the recall.

SUMMARY

Date of Recall:

Announced: October 10, 2024

Public Notification: October 16, 2024

Name(s) of Drug:

Ascorbic Acid Solution for Injection

Company Name:

STASKA Pharmaceuticals, Inc.

Drug Indication:

Vitamin C supplement

Product Description

Ascorbic Acid solution for injection (preservative-free, non-corn) 500mg/mL is distributed nationwide to pharmacies and facilities. It is available by prescription only. Each amber-colored vial bears the drug name, strength, lot number, and expiration date. Only licensed healthcare providers can administer this drug as it is not available to the general public.

Reason for Recall

Glass particulate is present in one lot of the vials. The FDA has not revealed how the manufacturer discovered the glass, only announcing its presence.

Impacts

Consumers who receive an intravenous injection of the solution are at serious risk of health outcomes related to the glass particulate. The particles may travel throughout the bloodstream and block vessels to vital organs, including the brain, heart, and lungs, leading to stroke or death.  

Lot Information

Healthcare workers: Check your stock carefully to ensure the recalled medication is removed and not administered to your patients. If you have the recalled drug in stock, read below for instructions on disposal.

Consumers: If you believe you have been administered this medication, ask your healthcare provider to verify that you have not received a dose from the recalled stock. Communicate any health changes with your physician immediately.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. Call your doctor right away. Report the use of the recalled medication.
2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
3. Consumers with questions may contact STASKA Pharmaceuticals, Inc. by phone at 1-402-782-2207 or 1-888-801-1370. They are available Monday through Friday from 8 a.m. to 5 p.m. CDT.
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Medical Facilities

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact STASKA Pharmaceuticals, Inc. by phone at 1-402-782-2207 or 1-888-801-1370. They are available Monday through Friday from 8 a.m. to 5 p.m. CDT. Notify them of any recalled batches that have already been administered to patients.
3. Notify affected patients of recalled batches that they have already received.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact STASKA Pharmaceuticals, Inc. by phone at 1-402-782-2207 or 1-888-801-1370. They are available Monday through Friday from 8 a.m. to 5 p.m. CDT. Notify them of any recalled batches that have already been shipped to medical facilities.
3. Notify affected facilities of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!