Recall Enforment Report D-0789-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 05-15-2017 for 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 The product was recalled due to lack of assurance of sterility: customer complaints received for the presence of leaks.. The product was distributed in Us And Foreign Countries: United Arab Emirates, Colombia, And Canada and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0789-201705-15-201705-24-2017Class II90,450 bagsMilrinone 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 0338-6010-48Lack of assurance of sterility: customer complaints received for the presence of leaks.Terminated
D-0788-201705-15-201705-24-2017Class II113,590 bagsFluconazole 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 0338-6046-48Lack of assurance of sterility: customer complaints received for the presence of leaks.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0338-6010Milrinone Lactate In Dextrose Milrinone LactateInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-6011Milrinone Lactate In Dextrose Milrinone LactateInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-6045Fluconazole FluconazoleInjection, SolutionIntravenousBaxter Healthcare CompanyHuman Prescription Drug
0338-6046Fluconazole FluconazoleInjection, SolutionIntravenousBaxter Healthcare CompanyHuman Prescription Drug