Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Ascorbic Acid Inj. Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Presence of glass particulates.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
- Recalling firm
- Staska Pharmaceuticals, Inc.
- Origin
- NE, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Oct 10, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0040-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other particulate / foreign matter recalls from 2024
All particulate / foreign matter recalls
Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
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