Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Lactated Ringers packaged in volume of 1000ML
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance
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
Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Affected NDC
0338-0117-03
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride NDC 00338-0117 |
SODIUM CHLORIDE 600 mg/100mL; SODIUM LACTATE 310 mg/100mL; POTASSIUM CHLORIDE 30 mg/100mL; CALCIUM CHLORIDE 20 mg/100mL | Injection, Solution Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Sentara Infusion Services
- NDC code
- 00338-0117-03
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0300-2023 · 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.
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