Drug 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
D-0789-2017
Product summary
- Event
- Event 77247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90,450 bags
- Official record key
drug-enforcement:D-0789-2017
Official wording
Reason: Lack of assurance of sterility: customer complaints received for the presence of leaks.
Code information: Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
Distribution pattern: US and foreign countries: United Arab Emirates, Colombia, and Canada
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility