West-ward Pharmaceutical Corp. recalls Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Scien
Recalled July 17, 2013 · FDA recall D-691-2013 · West-ward Pharmaceutical
Hazard
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D) · FDA Class III
Units
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Sold at
Nationwide
Description
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
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
Manufacturer(s)
West-ward Pharmaceutical Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →