Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Pantoprazole Sodium for Injection 40mg per vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
Affected NDCs
71839-0122-01
71839-0122-10
71839-0122-25
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 71839-0122 |
40 mg/10mL | Injection, Powder, for Solution Intravenous |
BE Pharmaceuticals Inc. | Rx |
- Recalling firm
- Be Pharmaceuticals Ag
- NDC code
- 71839-122-01
- Origin
- Switzerland
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1148-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 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
Class II · Moderate risk
Pantoprazole 30mg in Ns 7.5ml
Lack of sterility assurance
Other recalls by Be Pharmaceuticals Ag
All 2023 recalls
Class II · Moderate risk
Fosaprepitant for Injection 150 mg per vial
Lack of Sterility Assurance: Aseptic process simulation failure.
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.