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

FDA recall notice · announced May 24, 2017 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Notes

Distribution: US and foreign countries: United Arab Emirates, Colombia, and Canada
Lot/code information: Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
Quantity: 90,450 bags
Status: Terminated
Products in this recall event:
- Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 (D-0788-2017)
- 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 (D-0789-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.