FDAFDA · Food and drugs·Recall number D-0295-2015
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.
Published December 17, 2014 · Recall initiated: September 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MIDAZOLAM
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- U.S. Nationwide Including Puerto Rico
- UPC
- 0363323411183
- Lot
- Lot 6003827, Exp. Date 04/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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