Nicardipine Hydrochloride Injection 25 mg/10 mL recall: Impurity Out of Spec
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.…
Why was Nicardipine Hydrochloride Injection 25 mg/10 mL recalled?
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
- 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.…
- Recalling firm
- West-ward Pharmaceutical Corp.
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Distribution
- Nationwide
- Recall date
- July 17, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)