Recalls / Class I
Class ID-0152-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Midazolam
- Generic name
- Midazolam Hydrochloride
- Active ingredient
- Midazolam Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 76045-001, 76045-211, 76045-002, 76045-003
- FDA application
- ANDA203460
- Affected lot / code info
- Lot: 6400048
Why it was recalled
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
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5200 Corporate Pkwy, N/A, Wilson, North Carolina 27893-9412
Distribution
- Quantity
- 203136 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-27
- FDA classified
- 2018-01-04
- Posted by FDA
- 2018-01-10
- Terminated
- 2020-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0152-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.