CLASS II Drug recall · Reported 24 May 2017 · FDA Enforcement Report
Milrinone Lactate in 5% Dextrose Injection recalled by Baxter Healthcare
Baxter Healthcare is recalling Milrinone Lactate in 5% Dextrose Injection, 20 mg/ Single-Dose Intravia Container. The recall was initiated on 15 May 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0789-2017
- FDA event ID
- 77247
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2017
- FDA classified
- 18 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 May 2017 | Recall initiated by company | |
| 18 May 2017 | Classified by FDA | +3 days |
| 24 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: customer complaints received for the presence of leaks.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US and foreign countries: United Arab Emirates, Colombia, and Canada
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Which lots are affected?
Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
Where was it sold?
US and foreign countries: United Arab Emirates, Colombia, and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77247| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fluconazole Injection, USP, 200 mg recalled by Baxter HealthcareFluconazole | Baxter Healthcare | Sterility | IL |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Milrinone Lactate recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Milrinone Lactate Injection, USP 20mg/ (1mg/mL) recalledMilrinone Lactate | Caplin Steriles | Potency & Assay | Nationwide |
| Drug | CLASS II | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* recalled by Pfizer | Pfizer | Sterility | PR |
| Drug | CLASS II | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* recalled by Pfizer | Pfizer | Sterility | PR |