Drug product
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
D-0152-2018
Product summary
- Event
- Event 78396
- Status
- Terminated
- Classification
- Class I
- Quantity
- 203136 syringes
- Official record key
drug-enforcement:D-0152-2018
Official wording
Reason: Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Code information: Lot: 6400048
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label MIX-UP