FDA-Drug2013-07-17Class III
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
West-ward Pharmaceutical Corp.
Hazard
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Sold states
Nationwide
Affected count
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-691-2013Don't want to check this manually?
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