Drug product
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
D-0413-2015
Product summary
- Event
- Event 70375
- Status
- Terminated
- Classification
- Class III
- Quantity
- 78,090 vials
- Official record key
drug-enforcement:D-0413-2015
Official wording
Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Code information: Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent