Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergr
Summary
The FDA issued a Class I for Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx by Staska Pharmaceuticals, Inc.. Reason: Presence of Particulate Matter: Presence of glass particulates..
Details
Source
Drug Recall
External ID
D-0040-2025
Action Date
2024-11-13
Status
Terminated
Category
drug
Product Description
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Lot/Code Info: Lot #SP2400058, Exp 12/31/2024
Quantity Affected: 4773 vials
Reason for Recall
Presence of Particulate Matter: Presence of glass particulates.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-30
Company
Bennet, NE
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Staska Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Staska Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Staska Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0040-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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