Class III · Low risk
Milrinone Lactate Injection
Failed Impurities/Degradation Specifications
Milrinone Lactate in 5% Dextrose Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: customer complaints received for the presence of leaks.
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
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Affected NDC
0338-6010-48
Compare with the code on your package — it is the most precise check available.
Drug: Milrinone
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 |
|---|---|---|---|---|
| Milrinone Lactate in Dextrose Milrinone Lactate NDC 00338-6010 |
.2 mg/mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 0338-6010-48
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0789-2017 · 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 Milrinone recalls
See all
Class II · Moderate risk
Milrinone
Lack of sterility assurance
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone 200 mcg/mL in a) D5W-300 mL
Lack of Sterility Assurance
Other recalls by Baxter Healthcare Corporation
All 2017 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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