Recalls / Class II
Class IID-0456-2017
Product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
- Brand name
- Midazolam
- Generic name
- Midazolam Hydrochloride
- Active ingredient
- Midazolam Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 63323-411, 63323-412
- FDA application
- ANDA075154
- Affected lot / code info
- Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 47, 020 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-12-16
- FDA classified
- 2017-02-02
- Posted by FDA
- 2017-02-08
- Terminated
- 2018-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0456-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.