Reported Jul 17, 2013 · Terminated
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma…
West-ward Pharmaceutical Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: West-ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209
Is this the product you have?
- 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
- byWest-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
- Lot codes and dates
- Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
- Amount recalled
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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