Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Pantoprazole Sodium for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
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
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Affected NDC
55150-0202-00
Compare with the code on your package — it is the most precise check available.
Drug: Pantoprazole Category: Heartburn & Stomach Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pantoprazole Sodium NDC 55150-0202 |
40 mg/1 | Injection, Powder, for Solution Intravenous |
Eugia US LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-202-00
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0340-2018 · 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 Pantoprazole recalls
See all
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Other recalls by AuroMedics Pharma LLC
All 2017 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.