Drug recall D-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.
Reason for recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lots and codes
Lot 6003827, Exp. Date 04/2015
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 101,200 Vials
- Distribution
- U.S. Nationwide Including Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 27, 2012
- Terminated
- December 12, 2014
Related products
- Midazolam – drug information
- NDC 63323-411 Midazolam · Midazolam Hydrochloride 1 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-412 Midazolam · Midazolam Hydrochloride 5 mg/mL · Fresenius Kabi USA, LLC