Recalls / Class III
Class IIID-691-2013
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
- Brand name
- Nicardipine Hydrochloride
- Generic name
- Nicardipine Hydrochloride
- Active ingredient
- Nicardipine Hydrochloride
- Route
- Intravenous
- NDCs
- 0143-9633, 0143-9689, 0143-9634
- FDA application
- NDA022276
- Affected lot / code info
- Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Why it was recalled
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-13
- FDA classified
- 2013-07-11
- Posted by FDA
- 2013-07-17
- Terminated
- 2015-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-691-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.