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
Reported: July 17, 2013 Initiated: May 13, 2013 #D-691-2013
Product Description
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
Reason for Recall
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Details
- Recalling Firm
- West-ward Pharmaceutical Corp.
- Units Affected
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by West-ward Pharmaceutical Corp.. Units affected: Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2013. Severity: Low. Recall number: D-691-2013.
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