Recalls / Class II
Class IID-0295-2015
Product
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
- 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 6003827, Exp. Date 04/2015
Why it was recalled
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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
- 101,200 Vials
- Distribution pattern
- U.S. Nationwide Including Puerto Rico
Timeline
- Recall initiated
- 2012-09-27
- FDA classified
- 2014-12-10
- Posted by FDA
- 2014-12-17
- Terminated
- 2014-12-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0295-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.