D-0295-2015 Class II Terminated
FDA drug recall D-0295-2015 was initiated by Fresenius Kabi USA, LLC on Sep 27, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. The recall status is terminated (terminated Dec 12, 2014). Affected quantity: 101,200 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2014
- Initiation Date
- Sep 27, 2012
- Termination Date
- Dec 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101,200 Vials
Product Description
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.
Distribution Pattern
U.S. Nationwide Including Puerto Rico
Code Information
Lot 6003827, Exp. Date 04/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0295-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026