Elevated risk U.S. Food and Drug Administration

STASKA Pharmaceuticals Ascorbic Acid Solution for Injection recall: Device & Drug Safety – Presence of glass particulates

Recall published 2+ years ago

Device & Drug Safety – Presence of glass particulates

STASKA Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — glass

The company found glass in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

What the notice says: The administration of an injectable product containing particulate matter may result in local irritation or swelling.

Why it matters: Pieces of glass may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: glass is usually visible on an X-ray, and a swallowed shard is one of the cases where imaging is worth doing.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 10, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
STASKA Pharmaceuticals
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Ascorbic Acid Solution for Injection

What the company announced

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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12/31/2024

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg
  • 50 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Glass pieces

STASKA Pharmaceuticals — The company found glass in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  3. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  4. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: 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.

Company contact: STASKA Pharmaceuticals Inc. — Consumers: STASKA Pharmaceuticals, (402) 782-2207, 888-801-1370

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was STASKA Pharmaceuticals prescription & otc drugs recalled?

Device & Drug Safety – Presence of glass particulates The administration of an injectable product containing particulate matter may result in local irritation or swelling.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 12/31/2024. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: 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.

Where was the recalled product sold?

It was distributed nationwide.

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