West-ward Recalls Nicardipine Hydrochloride Injection Due to Impurity
West-ward Pharmaceutical Corp. is recalling specific lots of Nicardipine Hydrochloride Injection because they failed impurity specifications for a degradation product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling specific lots of Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials. The affected lots are PLNJ1201 and PLNJ1202, which were manufactured by Exela Pharma Sciences, LLC, and distributed nationwide.
The recall was initiated because the product failed impurity/degradation specifications. Specifically, the value for the impurity Nitrophenylpuridine Derivative (NPP-D) was out of specification. The FDA has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected lots and contact West-ward Pharmaceutical Corp. for further instructions or to return the product.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Distribution
Distributed nationwide across the United States.
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