Drug product
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
D-691-2013
Product summary
- Event
- Event 65287
- Status
- Terminated
- Classification
- Class III
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Official record key
drug-enforcement:D-691-2013
Official wording
Reason: Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Code information: Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification