D-0456-2017 Class II Terminated
FDA drug recall D-0456-2017 was initiated by Fresenius Kabi USA, LLC on Dec 16, 2016 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Jun 22, 2018). Affected quantity: 47, 020 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 8, 2017
- Initiation Date
- Dec 16, 2016
- Termination Date
- Jun 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47, 020 vials
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0456-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026