Drug Enforcement D-0040-2025

Presence of Particulate Matter: Presence of glass particulates.

Status

Terminated

Classification

Class I

Report Date

November 13, 2024

Termination Date

August 5, 2025

Product Information

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
Product quantity
4773 vials
Reason for recall
Presence of Particulate Matter: Presence of glass particulates.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Staska Pharmaceuticals, Inc.
Address
742 Evergreen Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0040-2025
Event ID
95503
Recall initiation date
September 30, 2024
Center classification date
November 7, 2024
Code info
Lot #SP2400058, Exp 12/31/2024
More code info