D-0152-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2018
- Initiation Date
- October 27, 2017
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203136 syringes
Product Description
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
Reason for Recall
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 6400048