D-0413-2015 Class III Terminated
FDA drug recall D-0413-2015 was initiated by Mylan Institutional LLC on Jan 23, 2015 and is designated Class III. Reason for recall: Subpotent Drug and Failed Impurities/Degradation Specifications The recall status is terminated (terminated Apr 11, 2016). Affected quantity: 78,090 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 25, 2015
- Initiation Date
- Jan 23, 2015
- Termination Date
- Apr 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78,090 vials
Product Description
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Reason for Recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide
Code Information
Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0413-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026