FDA Recall D-0152-2018
Fresenius Kabi USA, LLC · Wilson, NC
Class I — life-threatening Terminated 1074 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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
Recall record
- Recall number
D-0152-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2017-10-27
- Classified by FDA Center
- 2018-01-04
- FDA published
- 2018-01-10
- Terminated
- 2020-10-05
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Wilson, NC
Drug identification
- Brand name(s)
- MIDAZOLAM
- Generic name(s)
- MIDAZOLAM HYDROCHLORIDE
- Manufacturer(s)
- Fresenius Kabi USA, LLC
- NDC(s)
76045-001, 76045-211, 76045-002, 76045-003- Route(s)
- INTRAMUSCULAR, INTRAVENOUS